GEM Cap™

GUDID 00850001118071

Collagen dental regeneration membrane

Primary Device ID	00850001118071
NIH Device Record Key	ffa662f9-1c22-431c-b0ec-7d7f5919e832
Commercial Distribution Status	In Commercial Distribution
Brand Name	GEM Cap™
Version Model Number	LBCAP1216
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 Issuing Agency	Device ID
GS1	00850001118071 [Primary]

NPL	Barrier, Animal Source, Intraoral

Steralize Prior To Use	false
Device Is Sterile	true

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®	2018-11-19 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