AccessGUDID - DEVICE: BioMend™ Absorbable Collagen Membrane (10381780070733)

GUDID

Device Identifier (DI) Information

Brand Name: BioMend™ Absorbable Collagen Membrane
Version or Model: 0103
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0103
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780070733
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: BIOMEND 15 MM X 20 MM(0103) BioMend Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue generation procedures in periodontal defects to enhance regeneration of periodontal apparatus. The BioMend membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achilles) tendon.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58709	Collagen dental regeneration membrane	A sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and to regenerate bone defects around implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period. It is a pliable material made of animal-derived collagen (e.g., porcine) which may be fixed to soft tissues with sutures; it is applied between soft tissue and bone during periodontal flap surgery and applied to grafted bone defects in guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LYC	Bone grafting material, synthetic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: The product should be stored at room temperature. Avoid excessive heat and humidity.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 15mmx20mm

Device Record Status

Public Device Record Key: a8dc88bc-3fe9-4930-b71f-600b0cfcc491
Public Version Date: February 08, 2021
Public Version Number: 6
DI Record Publish Date: September 22, 2015