GEM™ Wound Dressing Foam

GUDID 10850001118207

Dental Wound Dressing Foam, 2cm x 4cm x 3mm

LYNCH BIOLOGICS, LLC

General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived

• Primary Device ID: 10850001118207
• NIH Device Record Key: c9981d40-bebd-4e8a-8d85-47f6c1be2435
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM™ Wound Dressing Foam
• Version Model Number: LBWDF
• Company DUNS: 079604282
• Company Name: LYNCH BIOLOGICS, LLC
• Device Count: 10
• 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

• Height: 1 Millimeter
• Length: 2 Centimeter
• Width: 4 Centimeter
• Height: 1 Millimeter
• Length: 2 Centimeter
• Width: 4 Centimeter
• Height: 1 Millimeter
• Length: 2 Centimeter
• Width: 4 Centimeter
• Height: 1 Millimeter
• Length: 2 Centimeter
• Width: 4 Centimeter
• Height: 1 Millimeter
• Length: 2 Centimeter
• Width: 4 Centimeter
• Height: 1 Millimeter
• Length: 2 Centimeter
• Width: 4 Centimeter
• Height: 1 Millimeter
• Length: 2 Centimeter
• Width: 4 Centimeter
• Height: 1 Millimeter
• Length: 2 Centimeter
• Width: 4 Centimeter
• Height: 1 Millimeter
• Length: 2 Centimeter
• Width: 4 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001118200 [Unit of Use]
GS1	10850001118207 [Primary]

FDA Product Code

• KGN: Dressing, Wound, Collagen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-07-07
• 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: 2020-07-07Dental Wound Dressing Foam, 2cm x 4cm x 3mm
• 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®: 2018-11-19 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