GEM™ Synthetic Bone Graft

GUDID 00850001118163

Synthetic Mineral-Collagen Composite Bone Graft, 0.5cc (9mm x 8mm)

LYNCH BIOLOGICS, LLC

Collagen dental regeneration membrane

• Primary Device ID: 00850001118163
• NIH Device Record Key: a3d0eafb-578d-47c9-bb0b-7e53b79c8cac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM™ Synthetic Bone Graft
• Version Model Number: LBSB050
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00850001118163 [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™ Synthetic Bone Graft]

• 00850001118187: Synthetic Mineral-Collagen Composite Bone Graft, 2.0cc (11mm x 21mm)
• 00850001118170: Synthetic Mineral-Collagen Composite Bone Graft, 1.0cc (11mm x 10mm)
• 00850001118163: Synthetic Mineral-Collagen Composite Bone Graft, 0.5cc (9mm x 8mm)