Self-Cath Closed System 50274

GUDID 05708932282987

Self-Cath Closed System. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. FR 16. Rx only.

Coloplast A/S

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 Single-administration urethral catheterization kit, single-use
Primary Device ID05708932282987
NIH Device Record Keyacf64f76-180a-4d53-ad40-13b9acd4a005
Commercial Distribution StatusIn Commercial Distribution
Brand NameSelf-Cath Closed System
Version Model Number50274
Catalog Number50274
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 Gauge16 French
Device Size Text, specify0
Catheter Gauge16 French
Catheter Working Length31 Centimeter
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Gauge16 French
Catheter Working Length31 Centimeter
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Gauge16 French
Catheter Working Length31 Centimeter
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Gauge16 French
Catheter Working Length31 Centimeter
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Gauge16 French
Catheter Working Length31 Centimeter
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Gauge16 French
Catheter Working Length31 Centimeter
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Gauge16 French
Catheter Working Length31 Centimeter
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Gauge16 French
Catheter Working Length31 Centimeter
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Gauge16 French
Catheter Working Length31 Centimeter
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Gauge16 French
Catheter Working Length31 Centimeter
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Gauge16 French
Catheter Working Length31 Centimeter
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Gauge16 French
Catheter Working Length31 Centimeter
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Gauge16 French
Catheter Working Length31 Centimeter
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Gauge16 French
Catheter Working Length31 Centimeter
Catheter Working Length12.2 Inch
Device Size Text, specify0
Catheter Gauge16 French
Catheter Working Length31 Centimeter
Catheter Working Length12.2 Inch
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if sterile barrier is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
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
GS105708932279222 [Primary]
GS105708932282987 [Package]
Contains: 05708932279222
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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