GEM™ Wound Dressing Tape

GUDID 10850001118191

Dental Wound Dressing Tape, 2.5cm x7.5cm x 1mm

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 ID10850001118191
NIH Device Record Key79ad9fa3-2714-428d-9a61-ab34c7396fed
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM™ Wound Dressing Tape
Version Model NumberLBWDT
Company DUNS079604282
Company NameLYNCH BIOLOGICS, LLC
Device Count10
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

Height1 Millimeter
Width7.5 Centimeter
Length2.5 Centimeter
Height1 Millimeter
Width7.5 Centimeter
Length2.5 Centimeter
Height1 Millimeter
Width7.5 Centimeter
Length2.5 Centimeter
Height1 Millimeter
Width7.5 Centimeter
Length2.5 Centimeter
Height1 Millimeter
Width7.5 Centimeter
Length2.5 Centimeter
Height1 Millimeter
Width7.5 Centimeter
Length2.5 Centimeter
Height1 Millimeter
Width7.5 Centimeter
Length2.5 Centimeter
Height1 Millimeter
Width7.5 Centimeter
Length2.5 Centimeter
Height1 Millimeter
Width7.5 Centimeter
Length2.5 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001118194 [Unit of Use]
GS110850001118191 [Primary]

FDA Product Code

KGNDressing, Wound, Collagen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-07-07
Device Publish Date2018-10-18

Devices Manufactured by LYNCH BIOLOGICS, LLC

10850001118191 - GEM™ Wound Dressing Tape2020-07-07Dental Wound Dressing Tape, 2.5cm x7.5cm x 1mm
10850001118191 - GEM™ Wound Dressing Tape2020-07-07 Dental Wound Dressing Tape, 2.5cm x7.5cm x 1mm
10850001118207 - GEM™ Wound Dressing Foam2020-07-07 Dental Wound Dressing Foam, 2cm x 4cm x 3mm
10850001118214 - GEM™ Wound Dressing Plug2020-07-07 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

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