SpeediCath Flex Set 28932

GUDID 05701780221641

SpeediCath Flex Set CH12

Coloplast A/S

Single-administration urethral catheterization kit, single-use
Primary Device ID05701780221641
NIH Device Record Key9b478032-dfbd-4c01-a9c9-194770e88043
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpeediCath Flex Set
Version Model Number28932
Catalog Number28932
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

Device Dimensions

Catheter Working Length33 Centimeter
Outer Diameter4 Millimeter
Outer Diameter0.16 Inch
Catheter Gauge12 French
Catheter Working Length33 Centimeter
Outer Diameter4 Millimeter
Outer Diameter0.16 Inch
Catheter Gauge12 French
Catheter Working Length33 Centimeter
Outer Diameter4 Millimeter
Outer Diameter0.16 Inch
Catheter Gauge12 French
Catheter Working Length33 Centimeter
Outer Diameter4 Millimeter
Outer Diameter0.16 Inch
Catheter Gauge12 French
Catheter Working Length33 Centimeter
Outer Diameter4 Millimeter
Outer Diameter0.16 Inch
Catheter Gauge12 French
Catheter Working Length33 Centimeter
Outer Diameter4 Millimeter
Outer Diameter0.16 Inch
Catheter Gauge12 French
Catheter Working Length33 Centimeter
Outer Diameter4 Millimeter
Outer Diameter0.16 Inch
Catheter Gauge12 French
Catheter Working Length33 Centimeter
Outer Diameter4 Millimeter
Outer Diameter0.16 Inch
Catheter Gauge12 French
Catheter Working Length33 Centimeter
Outer Diameter4 Millimeter
Outer Diameter0.16 Inch
Catheter Gauge12 French
Catheter Working Length33 Centimeter
Outer Diameter4 Millimeter
Outer Diameter0.16 Inch
Catheter Gauge12 French
Catheter Working Length33 Centimeter
Outer Diameter4 Millimeter
Outer Diameter0.16 Inch
Catheter Gauge12 French
Catheter Working Length33 Centimeter
Outer Diameter4 Millimeter
Outer Diameter0.16 Inch
Catheter Gauge12 French
Catheter Working Length33 Centimeter
Outer Diameter4 Millimeter
Outer Diameter0.16 Inch
Catheter Gauge12 French
Catheter Working Length33 Centimeter
Outer Diameter4 Millimeter
Outer Diameter0.16 Inch
Catheter Gauge12 French
Catheter Working Length33 Centimeter
Outer Diameter4 Millimeter
Outer Diameter0.16 Inch
Catheter Gauge12 French

Device Identifiers

Device Issuing AgencyDevice ID
GS105701780221535 [Package]
Contains: 05708932748476
Package: Retail Box [30 Units]
In Commercial Distribution
GS105701780221641 [Package]
Contains: 05701780221535
Package: Shipper Box [3 Units]
In Commercial Distribution
GS105708932748476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZDCATHETER, STRAIGHT

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-17
Device Publish Date2022-10-09

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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