Red Rubber Urethral Catheters

GUDID 00616784506531

DYNAREX CORPORATION

Single-administration urethral drainage catheter
Primary Device ID00616784506531
NIH Device Record Key1c33a5f4-f3f9-45b4-8c09-51eb580c5d3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRed Rubber Urethral Catheters
Version Model Number5065
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count10
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784506517 [Unit of Use]
GS100616784506524 [Primary]
GS100616784506531 [Package]
Contains: 00616784506524
Package: [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EYBCatheter, Ureteral, Gastro-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Red Rubber Urethral Catheters]

006167845070335070
006167845069375069
006167845068385068
006167845067395067
006167845066305066
006167845065315065
006167845064325064
006167845063335063
006167845062345062

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