Silicone Foley Catheters

GUDID 00616784508733

DYNAREX CORPORATION

Indwelling urethral drainage catheter
Primary Device ID00616784508733
NIH Device Record Keycb2a721b-79d5-4e90-83bc-50052a3b7408
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Foley Catheters
Version Model Number5087
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784508719 [Unit of Use]
GS100616784508726 [Primary]
GS100616784508733 [Package]
Contains: 00616784508726
Package: [10 Units]
In Commercial Distribution

FDA Product Code

EZLCatheter, Retention Type, Balloon

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-07-12
Device Publish Date2016-09-24

On-Brand Devices [Silicone Foley Catheters]

006167845089315089
006167845088325088
006167845087335087
006167845086345086
006167845085355085
006167845084365084
006167845083375083
006167845082385082
006167845081395081
006167845080305080
006167845079345079
006167845078355078
006167845077365077
006167845076375076
006167845075385075
006167845074395074

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