GTKS Medical C5513G

GUDID 16975424191379

Microscope Drape, Leica, Bayonet, 137x381cm -54"x150"

EXACT MEDICAL MANUFACTURING, INC.

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Primary Device ID16975424191379
NIH Device Record Keya149c3de-c3fb-4c73-bafa-7a5c9933fe6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGTKS Medical
Version Model NumberC5513G
Catalog NumberC5513G
Company DUNS014464314
Company NameEXACT MEDICAL MANUFACTURING, INC.
Device Count1
DM Exempttrue
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106975424191372 [Primary]
GS116975424191379 [Package]
Contains: 06975424191372
Package: Case [10 Units]
In Commercial Distribution
GS126975424191376 [Package]
Package: Case [1 Units]
In Commercial Distribution

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-12
Device Publish Date2023-04-04

On-Brand Devices [GTKS Medical]

16975424191386Microscope Drape, Leica, Bayonet, 137x305cm - 54"x120"
16975424191379Microscope Drape, Leica, Bayonet, 137x381cm -54"x150"
16975424191362Microscope Drape- Leica 137x305cm - 54"x120"

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