Urethral Intermittent Catheter Tray

GUDID 00616784492834

DYNAREX CORPORATION

Urethral catheterization support kit, urinary drainage
Primary Device ID00616784492834
NIH Device Record Keybfa53f2c-9c1b-465b-b33f-27f4a5bcf20f
Commercial Distribution StatusIn Commercial Distribution
Brand NameUrethral Intermittent Catheter Tray
Version Model Number4928
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count20
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784492827 [Unit of Use]
GS100616784492834 [Primary]

FDA Product Code

OHRCatheter Care Tray

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-04-09
Device Publish Date2016-11-22

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