Global Headquarters
2300 Riverchase Center
Birmingham, AL 35244
USA
tel: 888.246.8338
tel: 205.967.7880
fax: 205.870.0304
BioHorizons Canada
21 Amber Street, Unit #6
Markham, Ontario L3R 4Z3
Canada
tel: 866.468.8338
fax: 905.944.1894
BioHorizons Chile, S.A.
Av. Manquehue Norte 1337 Office 31
Vitacura
Santiago
Chile
tel: +56 (2) 23619519
fax: +56 (2) 361.9521
BioHorizons Italia Srl
Via Ettore Cristoni, 88
40033 Casalecchio di Reno (BO) Italy
numero verde +800.063.040
tel. +39.051.59.07.00
fax +39.051.57.61.06
BioHorizons México
Av. Insurgentes # 64 colonia Juarez
Torre B oficina 407
Delegación Cuauhtémoc
CP 06600 CDMX
México
tel. 800.953.0498
tel. 011.52.5511638675
Spanish Office
BioHorizons Spain
Calle Oruro, 9
28016 Madrid,
Spain
tel: +34.91.713.10.84
fax: +34.91.355.83.75
BioHorizons Camlog UK & Ireland
Reflex
Cain Road
Bracknell
Berkshire RG12 1HL
United Kingdom
tel: +44 (0)1344 752560
AlloDerm SELECT GBR Regenerative Tissue Matrix utilizes that same proprietary processing that maintains tissue integrity and supports tissue regeneration by allowing rapid revascularization, fibroblast repopulation and a minimal inflammatory response.1,2 AlloDerm SELECT GBR RTM is used as an effective barrier membrane that transitions into the patient's own tissue (Thickness range of 1.0 +- 0.2mm).3
AlloDerm SELECT™ Regenerative Tissue Matrix (RTM) is ready-to-use and designed to have similar clinical and intraoperative performance to AlloDerm™ RTM
INDICATIONS AND IMPORTANT SAFETY INFORMATION
INDICATIONS
ALLODERM SELECT™ Regenerative Tissue Matrix (ALLODERM SELECT™ RTM refers to both ALLODERM SELECT™ RTM and ALLODERM SELECT GBR™ RTM products) is intended to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument including gingival. This product is intended for one patient on a single occasion. ALLODERM SELECT™ RTM is not indicated for use as a dural substitute or intended for use in veterinary applications.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
ALLODERM SELECT™ RTM should not be used in patients with a known sensitivity to any of the antibiotics listed on the package and/or Polysorbate 20.
WARNINGS
Processing of the tissue, laboratory testing, and careful donor screening minimize the risk of the donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, ALLODERM SELECT™ RTM is not guaranteed to be free of all pathogens. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of ALLODERM SELECT™ RTM.
DO NOT re-sterilize ALLODERM SELECT™ RTM. DO NOT reuse once the tissue graft has been removed from the packaging and/or is in contact with a patient. Discard all open and unused portions of the product in accordance with standard medical practice and institutional protocols for disposal of human tissue. Once a package or container seal has been compromised, the tissue shall be either transplanted, if appropriate, or otherwise discarded. DO NOT use if the foil pouch is opened or damaged. DO NOT use if the seal is broken or compromised. DO NOT use if the temperature monitoring device does not display “OK”. DO NOT use after the expiration date noted on the label. Transfer ALLODERM SELECT™ RTM from the foil pouch aseptically. DO NOT place the foil pouch in the sterile field.
PRECAUTIONS
Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for implanting ALLODERM SELECT™ RTM as such conditions may compromise successful clinical outcome. Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.
ALLODERM SELECT™ RTM has a distinct basement membrane (upper) and dermal surface (lower). When applied as an implant, it is recommended that the dermal side be placed against the most vascular tissue. Soak the tissue for a minimum of 2 minutes using a sterile basin and room temperature sterile saline or room temperature sterile lactated Ringer’s solution to cover the tissue. If any hair is visible, remove using aseptic technique before implantation.
ALLODERM SELECT™ RTM should be hydrated and moist when the package is opened. DO NOT use if this product is dry. Use of this product is limited to specific health professionals (e.g., physicians, dentists, and/or podiatrists). Certain considerations should be made to reduce the risk of adverse events when performing surgical procedures using a tissue graft. Please see the Instructions for Use (IFU) for more information on patient/product selection and surgical procedures involving tissue implantation before using ALLODERM SELECT™ RTM.
ADVERSE EVENTS
Potential adverse events which may result from surgical procedures associated with the implant of a tissue graft include, but are not limited to the following: wound or systemic infection; dehiscence; hypersensitive, allergic or other immune response; and sloughing or failure of the graft.
ALLODERM SELECT™ RTM is available by prescription only.
For more information, please see the Instructions for Use (IFU) for ALLODERM SELECT™ RTM and ALLODERM SELECT GBR™ RTM or call 1.800.678.1605 for a copy of the IFU.
To report an adverse reaction, please call BioHorizons Customer Care at 1.888.246.8338
ALLODERM™, ALLODERM SELECT™, ALLODERM GBR™, and their designs are trademarks of LifeCell Corporation, an AbbVie company. © 2021 BioHorizons and AbbVie. All rights reserved.
Global Headquarters
2300 Riverchase Center
Birmingham, AL 35244
USA
tel: 888.246.8338
tel: 205.967.7880
fax: 205.870.0304
BioHorizons Canada
21 Amber Street, Unit #6
Markham, Ontario L3R 4Z3
Canada
tel: 866.468.8338
fax: 905.944.1894
BioHorizons Chile, S.A.
Av. Manquehue Norte 1337 Office 31
Vitacura
Santiago
Chile
tel: +56 (2) 23619519
fax: +56 (2) 361.9521
BioHorizons Italia Srl
Via Ettore Cristoni, 88
40033 Casalecchio di Reno (BO) Italy
numero verde +800.063.040
tel. +39.051.59.07.00
fax +39.051.57.61.06
BioHorizons Mexico
Cracovia No. 72 Torre B, Oficina: BGO-07, Col. San Ángel
CP: 01000, Ciudad de México, Álvaro Obregón, CDMX
tel. 800 953 0498
Spanish Office
BioHorizons Spain
Calle Oruro, 9
28016 Madrid,
Spain
tel: +34.91.713.10.84
fax: +34.91.355.83.75
BioHorizons Camlog UK & Ireland
Richmond House
Oldbury Road
Bracknell
Berkshire RG12 8TQ
United Kingdom
tel: +44 (0)1344 752560
fax: +44 (0)1344 868049
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