Self-Cath Closed System 50272

GUDID 05708932282963

Self-Cath Closed System. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. FR 12. Rx only.

Coloplast A/S

Single-administration urethral drainage catheter Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use
Primary Device ID05708932282963
NIH Device Record Keycc0ac830-4839-4751-8d91-5f3414227d14
Commercial Distribution StatusIn Commercial Distribution
Brand NameSelf-Cath Closed System
Version Model Number50272
Catalog Number50272
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
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com

Device Dimensions

Catheter Gauge12 French
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Working Length31 Centimeter
Catheter Gauge12 French
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Working Length31 Centimeter
Catheter Gauge12 French
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Working Length31 Centimeter
Catheter Gauge12 French
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Working Length31 Centimeter
Catheter Gauge12 French
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Working Length31 Centimeter
Catheter Gauge12 French
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Working Length31 Centimeter
Catheter Gauge12 French
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Working Length31 Centimeter
Catheter Gauge12 French
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Working Length31 Centimeter
Catheter Gauge12 French
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Working Length31 Centimeter
Catheter Gauge12 French
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Working Length31 Centimeter
Catheter Gauge12 French
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Working Length31 Centimeter
Catheter Gauge12 French
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Working Length31 Centimeter
Catheter Gauge12 French
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Working Length31 Centimeter
Catheter Gauge12 French
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Working Length31 Centimeter
Catheter Gauge12 French
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Working Length31 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if sterile barrier is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU.

Device Identifiers

Device Issuing AgencyDevice ID
GS105708932279208 [Primary]
GS105708932282963 [Package]
Contains: 05708932279208
Package: Shipper box [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

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 Date2016-09-02

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