SpeediCath Flex Set 28941

GUDID 05708932755856

Coloplast A/S

Single-administration urethral catheterization kit, single-use
Primary Device ID05708932755856
NIH Device Record Key08cf0e6c-2278-4b44-ac71-fa3e5b8b17da
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpeediCath Flex Set
Version Model Number28941
Catalog Number28941
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 Kittrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Gauge10 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Gauge10 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Gauge10 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Gauge10 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Gauge10 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Gauge10 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Gauge10 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Gauge10 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Gauge10 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Gauge10 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Gauge10 French
Device Size Text, specify0
Catheter Working Length33 Centimeter
Catheter Gauge10 French

Device Identifiers

Device Issuing AgencyDevice ID
GS105708932747684 [Primary]
GS105708932755856 [Package]
Contains: 05708932747684
Package: Shipper Box [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCMTray, catheterization, sterile urethral, with or without catheter (kit)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-09
Device Publish Date2022-12-01

On-Brand Devices [SpeediCath Flex Set]

05701780221559SpeediCath Flex Set CH16
05701780221658SpeediCath Flex Set CH14
05701780221641SpeediCath Flex Set CH12
05701780221627SpeediCath Flex Set CH10
0570893275308128946
0570893275589428944
0570893275587028942
0570893275585628941

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