Irrigation Set

GUDID 08056646509980

OMNIA SRL

Disposable surgical irrigation/aspiration system
Primary Device ID08056646509980
NIH Device Record Key7048dd94-34fb-47f9-acdc-d0223a0f54e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameIrrigation Set
Version Model Number32.F0256.00
Company DUNS447696675
Company NameOMNIA SRL
Device Count10
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108056646509980 [Unit of Use]
GS108056646509997 [Primary]

FDA Product Code

EFSUnit, Oral Irrigation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-19
Device Publish Date2024-11-11

On-Brand Devices [Irrigation Set]

0805664650998032.F0256.00
0805664650996632.F0265.00

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