Light blue gown with elastics (length 120 cm)

GUDID 08052141310311

Light blue gown with elastics (length 120 cm)

OMNIA SRL

Surgical gown, single-use
Primary Device ID08052141310311
NIH Device Record Keyda759c4b-6ee3-492c-881f-4429139396bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameLight blue gown with elastics (length 120 cm)
Version Model Number22.D1307.00
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
GS108052141310311 [Unit of Use]
GS108052141310328 [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 [Light blue gown with elastics (length 120 cm)]

08056646507344Light blue gown with elastics (length 120 cm)
08052141310311Light blue gown with elastics (length 120 cm)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.