GEM™ Bone Graft

GUDID 00850001118125

Osteoconductive Bone Matrix, 1.0cc (Particle Size 1.0-2.0mm)

LYNCH BIOLOGICS, LLC

Dental bone matrix implant, animal-derived
Primary Device ID00850001118125
NIH Device Record Key1b3a1e38-1c40-4a9c-80da-cbca3a262c9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM™ Bone Graft
Version Model NumberLBNB1020
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
GS100850001118125 [Primary]

FDA Product Code

NPMBone Grafting Material, Animal Source

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™ Bone Graft]

00850001118156Osteoconductive Bone Matrix in Syringe, 0.5cc (Particle Size 0.25-1.0mm)
00850001118149Osteoconductive Bone Matrix in Syringe, 0.25cc (Particle Size 0.25-1.0mm)
00850001118132Osteoconductive Bone Matrix, 2.0cc (Particle Size 1.0-2.0mm)
00850001118125Osteoconductive Bone Matrix, 1.0cc (Particle Size 1.0-2.0mm)
00850001118118Osteoconductive Bone Matrix, 4.0cc (Particle Size 0.25-1.0mm)
00850001118101Osteoconductive Bone Matrix, 2.0cc (Particle Size 0.25-1.0mm)
00850001118095Osteoconductive Bone Matrix, 1.0cc (Particle Size 0.25-1.0mm)
00850001118088Osteoconductive Bone Matrix, 0.5cc (Particle Size 0.25-1.0mm)

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