Overhead Cover Gown PM4-88335

GUDID 10842942013949

Overhead Cover Gown, Thumbloop Cuff, Open Back, Universal, Blue.

priMED Medical Products Inc

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Primary Device ID10842942013949
NIH Device Record Keyf45c4b08-6025-4bf6-af02-cee2cf27cc90
Commercial Distribution StatusIn Commercial Distribution
Brand NameOverhead Cover Gown
Version Model NumberBlue
Catalog NumberPM4-88335
Company DUNS253287569
Company NamepriMED Medical Products Inc
Device Count20
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100842942013942 [Primary]
GS110842942013949 [Package]
Contains: 00842942013942
Package: Case [6 Units]
In Commercial Distribution
GS190842942013945 [Unit of Use]

FDA Product Code

FMEGown, Examination

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-09
Device Publish Date2020-09-01

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