GEM™ Synthetic Bone Graft

GUDID 00850001118187

Synthetic Mineral-Collagen Composite Bone Graft, 2.0cc (11mm x 21mm)

LYNCH BIOLOGICS, LLC

Collagen dental regeneration membrane
Primary Device ID00850001118187
NIH Device Record Keycccbaab7-9869-48f6-b835-ade9a46c7428
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM™ Synthetic Bone Graft
Version Model NumberLBSB200
Company DUNS079604282
Company NameLYNCH BIOLOGICS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001118187 [Primary]

FDA Product Code

NPLBarrier, Animal Source, Intraoral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-19
Device Publish Date2018-10-18

On-Brand Devices [GEM™ Synthetic Bone Graft]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.