Silicone Supra-Pubic Catheter Exchange Set (Ordina

GUDID 04710961934196

FORTUNE MEDICAL INSTRUMENT CORP.

Suprapubic drainage catheter
Primary Device ID04710961934196
NIH Device Record Keyf61e2db5-b7f6-4fe4-a9ba-24d0ac7c116a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Supra-Pubic Catheter Exchange Set (Ordina
Version Model Number1890-8212
Company DUNS656763489
Company NameFORTUNE MEDICAL INSTRUMENT CORP.
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 Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104710961934196 [Primary]
GS114710961934193 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KOBCatheter, Suprapubic (And Accessories)

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 Date2016-03-15

On-Brand Devices [Silicone Supra-Pubic Catheter Exchange Set (Ordina]

047109619342571890-8224
047109619342401890-8222
047109619342331890-8220
047109619342261890-8218
047109619342191890-8216
047109619342021890-8214
047109619341961890-8212

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.