O'Neil Intermittent Urinary Catheter ONSM12

GUDID 09350902001195

GO MEDICAL INDUSTRIES PTY. LTD.

Intermittent urethral catheterization kit
Primary Device ID09350902001195
NIH Device Record Key24740ccf-8f61-483c-af69-b6a68a78702c
Commercial Distribution StatusIn Commercial Distribution
Brand NameO'Neil Intermittent Urinary Catheter
Version Model Number12 Gauge
Catalog NumberONSM12
Company DUNS757634266
Company NameGO MEDICAL INDUSTRIES PTY. LTD.
Device Count1
DM Exemptfalse
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109350902001188 [Primary]
GS109350902001195 [Package]
Contains: 09350902001188
Package: Carton [200 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GBMCatheter, Urethral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-11-28
Device Publish Date2017-05-17