Yellow gown with cuffs (length 120 cm)

GUDID 08052141310298

Yellow gown with cuffs (length 120 cm)

OMNIA SRL

Surgical gown, single-use
Primary Device ID08052141310298
NIH Device Record Key8d805ed1-3a45-4f97-beba-e85d0752180a
Commercial Distribution StatusIn Commercial Distribution
Brand NameYellow gown with cuffs (length 120 cm)
Version Model Number22.D1304.00
Company DUNS447696675
Company NameOMNIA SRL
Device Count50
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108052141310298 [Unit of Use]
GS108052141310304 [Primary]

FDA Product Code

OEANon-Surgical Isolation Gown

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-30
Device Publish Date2023-06-22

On-Brand Devices [Yellow gown with cuffs (length 120 cm)]

08056646507320Yellow gown with cuffs (length 120 cm)
08052141310298Yellow gown with cuffs (length 120 cm)

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