United Urologics Closed System Catheter

GUDID 00818016020130

UNITED UROLOGICS INC

Single-administration urethral catheterization kit, single-use
Primary Device ID00818016020130
NIH Device Record Key53f6c5dd-cc6b-4d06-8172-aa8a2bc3b0e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnited Urologics Closed System Catheter
Version Model NumberUU12C
Company DUNS080428707
Company NameUNITED UROLOGICS INC
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100818016020130 [Primary]
GS110818016020137 [Package]
Package: [100 Units]
In Commercial Distribution

FDA Product Code

KODCatheter, Urological

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-03-22

On-Brand Devices [United Urologics Closed System Catheter]

00818016020154UU16C
00818016020147UU14C
00818016020130UU12C
00818016020123UU14S
00818016020116UU12S
00818016020103UU16R
00818016020093UU14R
00818016020086UU12R
00818016020079UU18
00818016020062UU16
00818016020055UU14
00818016020048UU12
00818016020031UU10
00818016020024UU08
00818016020109UU16R
00818016020635UU16R

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