BioMend® Extend™ Absorbable Collagen Membrane

Basic Information

• Brand Name: BioMend® Extend™ Absorbable Collagen Membrane
• Primary DI: 10381780070788
• Version / Model: 0142
• Catalog Number: 0142
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-22
• Public Version: 5
• Public Version Date: 2020-09-22
• Public Version Status: Update
• Public Device Record Key: 0e0b6c0b-a180-4b1d-98d3-ed46506d42b7

Device Description

BIOMEND EXTEND 30MM X 40MM (0142) BioMend Extend 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 Extend membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achilles) tendon.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYC	Bone grafting material, synthetic	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30381780070782	GS1	CAS	12	In Commercial Distribution
Primary	10381780070788	GS1
Secondary	M26921830000201	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K992216	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			30mmx40mm

Storage Conditions

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