TheraBond 3D antimicrobial barrier systems

GUDID 10856040008097

3D Island Dressing 4in x 12in

ARGENTUM MEDICAL, LLC

Adhesive bandage
Primary Device ID10856040008097
NIH Device Record Key469634c4-0c2e-4107-846a-2cab3037091f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTheraBond 3D antimicrobial barrier systems
Version Model Number3DAI-412
Company DUNS091449079
Company NameARGENTUM MEDICAL, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100856040008090 [Primary]
GS110856040008097 [Package]
Contains: 00856040008090
Package: [5 Units]
In Commercial Distribution

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-08
Device Publish Date2020-09-30

On-Brand Devices [TheraBond 3D antimicrobial barrier systems ]

108560400081653D Wrap Dressing 6in x 96in
108560400081583D Wrap Dressing 4in x 72in
108560400081413D XS Island Dressing 4in x 14in
108560400081343D XS Island Dressing 4in x 10in
108560400081273D Island Dressing 4in x 8in
108560400081103D Island Dressing 4in x 6in
108560400081033D Island Dressing 4in x 5in
108560400080973D Island Dressing 4in x 12in
108560400080803D Island Dressing 4in x 10in
108560400080733D Island Dressing 2in x 2in
108560400080663D Contact Dressing 8in x 16in
108560400080593D Contact Dressing 4in x 8in
108560400080423D Contact Dressing 4.25in x 4.25in
108560400080353D Contact Dressing 24in x 24in
108560400080283D Contact Dressing 16in x 16in
108560400080113D Contact Dressing 1.5in x 6in
008560400080073D Contact Dressing 1.5in x 10in

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