Intermittent Catheter

GUDID 00616784498331

DYNAREX CORPORATION

Single-administration urethral drainage/irrigation catheter
Primary Device ID00616784498331
NIH Device Record Key0892e3be-1de7-449f-aae1-7d1f7dfe2750
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntermittent Catheter
Version Model Number4983
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count50
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784498317 [Unit of Use]
GS100616784498324 [Primary]
GS100616784498331 [Package]
Contains: 00616784498324
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZDCatheter, Straight

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 [Intermittent Catheter]

006167844995364995
006167844994374994
006167844993384993
006167844992394992
006167844991304991
006167844986384986
006167844985394985
006167844984304984
006167844983314983
006167844982324982
006167844981334981

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