United Urologics Closed System Kits

GUDID 00818016020192

UNITED UROLOGICS INC

Single-administration urethral catheterization kit, single-use
Primary Device ID00818016020192
NIH Device Record Key4c5c8b25-027e-450c-877a-0cccb5e1d59b
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnited Urologics Closed System Kits
Version Model NumberUU12K
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
GS100818016020192 [Primary]
GS110818016020199 [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

Devices Manufactured by UNITED UROLOGICS INC

00818016020635 - United Urologics Closed System Catheter2019-11-18
00818016020109 - United Urologics Closed System Catheter2019-11-18
10818016020311 - United Urologics Insertion Kit2019-04-09
00818016020017 - United Urologics Closed System Catheter Kit2018-03-29
00818016020024 - United Urologics Closed System Catheter2018-03-29
00818016020031 - United Urologics Closed System Catheter2018-03-29
00818016020048 - United Urologics Closed System Catheter2018-03-29
00818016020055 - United Urologics Closed System Catheter2018-03-29

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