Closed Circuit Foley Catheter Tray - Sterile - 18 FR

GUDID 00616784500737

DYNAREX CORPORATION

Urethral catheterization support kit, urinary drainage
Primary Device ID00616784500737
NIH Device Record Keybeb4a48d-d250-4e8a-9a8a-49f58858bffd
Commercial Distribution StatusIn Commercial Distribution
Brand NameClosed Circuit Foley Catheter Tray - Sterile - 18 FR
Version Model Number5007
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count10
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784500720 [Unit of Use]
GS100616784500737 [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 Number2
Public Version Date2019-04-09
Device Publish Date2018-08-18

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