SpeediCath Flex Coude 28912

GUDID 05708932643610

Ready to use male catheter. Pocket Size. Sterile urinary catheter for intermittent catheterization.

Coloplast A/S

Single-administration urethral drainage catheter
Primary Device ID05708932643610
NIH Device Record Key511e77ce-13f5-45de-bb99-297100287731
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpeediCath Flex Coude
Version Model Number28912
Catalog Number28912
Company DUNS305524696
Company NameColoplast A/S
Device Count1
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com

Device Dimensions

Outer Diameter4 Millimeter
Device Size Text, specify0
Length17.32 Inch
Length44 Centimeter
Catheter Gauge12 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS105708932017060 [Primary]
GS105708932643610 [Package]
Contains: 05708932017060
Package: retail box [30 Units]
In Commercial Distribution
GS105708932643641 [Package]
Package: shipper box [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GBMCATHETER, URETHRAL

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 Date2016-11-04

On-Brand Devices [SpeediCath Flex Coude]

05708932017244Ready to use male catheter. Sterile urinary catheter for intermittent catheterization.
05708932643689Ready to use male catheter. Sterile urinary catheter for intermittent catheterization.
05708932643672Ready to use male catheter. Sterile urinary catheter for intermittent catheterization.
05708932643665Ready to use male catheter. Sterile urinary catheter for intermittent catheterization.
05708932643658Ready to use male catheter. Pocket Size. Sterile urinary catheter for intermittent catheterizati
05708932643610Ready to use male catheter. Pocket Size. Sterile urinary catheter for intermittent catheterizati
05708932643603Ready to use male catheter. Pocket Size. Sterile urinary catheter for intermittent catheterizati

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