GEM 21S®

GUDID 00850001118002

Growth-Factor Enhanced Matrix for Periodontal Regeneration

LYNCH BIOLOGICS, LLC

Periodontal root surface regeneration material

• Primary Device ID: 00850001118002
• NIH Device Record Key: 457b7521-fbca-448d-b068-74c0a7031f94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM 21S®
• Version Model Number: LBGEM05
• 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: true
• 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

• Weight: 0.5 Gram

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001118002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040013

FDA Product Code

• NPZ: Bone Grafting Material, Dental, With Biologic Component

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

Devices Manufactured by LYNCH BIOLOGICS, LLC

• 10850001118191 - GEM™ Wound Dressing Tape: 2020-07-07 Dental Wound Dressing Tape, 2.5cm x7.5cm x 1mm
• 10850001118207 - GEM™ Wound Dressing Foam: 2020-07-07 Dental Wound Dressing Foam, 2cm x 4cm x 3mm
• 10850001118214 - GEM™ Wound Dressing Plug: 2020-07-07 Dental Wound Dressing Plug, 10 x 20mm
• 00850001118002 - GEM 21S®: 2018-11-19Growth-Factor Enhanced Matrix for Periodontal Regeneration
• 00850001118002 - GEM 21S®: 2018-11-19 Growth-Factor Enhanced Matrix for Periodontal Regeneration
• 00850001118019 - GEM Adapt™: 2018-11-19 Resorbable Collagen Membrane, 15mm x 20mm
• 00850001118026 - GEM Adapt™: 2018-11-19 Resorbable Collagen Membrane, 20mm x 30mm
• 00850001118033 - GEM Adapt™: 2018-11-19 Resorbable Collagen Membrane, 30mm x 40mm
• 00850001118040 - GEM Extend™: 2018-11-19 Resorbable Collagen Membrane, 15mm x 20mm