Austin Medical

GUDID 00850017635487

Drape, Mobile Radiation Barrier

EXACT MEDICAL MANUFACTURING, INC.

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Primary Device ID00850017635487
NIH Device Record Key33a53faa-9acf-49ee-bde8-93d69a699117
Commercial Distribution StatusIn Commercial Distribution
Brand NameAustin Medical
Version Model NumberX800-0117
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
GS100850017635487 [Primary]

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 Date2023-06-16
Device Publish Date2023-06-08

On-Brand Devices [Austin Medical]

00850003355481Tauro Towel, Single, Green
00850003355467Tauro Towel, Knee Roll
10850003355440Tauro Towel, Triple
10850003355433Tauro Towel, Double
10850003355426Tauro Towel, Single
26975424192274Hemorrhage View C-Section Drape, sterile
00850017635487Drape, Mobile Radiation Barrier
10850017635460Bag, L-Femoral

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