GEM Extend™

GUDID 00850001118040

Resorbable Collagen Membrane, 15mm x 20mm

LYNCH BIOLOGICS, LLC

Collagen dental regeneration membrane

• Primary Device ID: 00850001118040
• NIH Device Record Key: 2e444573-3d66-48a2-8759-1577b18c4989
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM Extend™
• Version Model Number: LBEXT1520
• Company DUNS: 079604282
• Company Name: LYNCH BIOLOGICS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 15 Millimeter
• Length: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001118040 [Primary]

FDA Product Code

• NPL: Barrier, Animal Source, Intraoral

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-19
• Device Publish Date: 2018-10-18

On-Brand Devices [GEM Extend™]

• 00850001118064: Resorbable Collagen Membrane, 30mm x 40mm
• 00850001118057: Resorbable Collagen Membrane, 20mm x 30mm
• 00850001118040: Resorbable Collagen Membrane, 15mm x 20mm