GEM Extend™

GUDID 00850001118040

Resorbable Collagen Membrane, 15mm x 20mm

LYNCH BIOLOGICS, LLC

Collagen dental regeneration membrane
Primary Device ID00850001118040
NIH Device Record Key2e444573-3d66-48a2-8759-1577b18c4989
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM Extend™
Version Model NumberLBEXT1520
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 Dimensions

Length15 Millimeter
Length15 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001118040 [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 Extend™]

00850001118064Resorbable Collagen Membrane, 30mm x 40mm
00850001118057Resorbable Collagen Membrane, 20mm x 30mm
00850001118040Resorbable Collagen Membrane, 15mm x 20mm

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