Self Cath 50522

GUDID 05708932279932

Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Olive Tip Coude w/Guide Stripe. Male. FR 12. 16 in. 40 cm. Rx only.

Coloplast A/S

Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter
Primary Device ID05708932279932
NIH Device Record Key888cb095-d302-4159-98ca-cd2fbf7278aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameSelf Cath
Version Model Number50522
Catalog Number50522
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
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
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

Length40 Centimeter
Device Size Text, specify0
Length16 Inch
Catheter Gauge12 French
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0
Catheter Gauge12 French
Catheter Working Length38 Centimeter
Catheter Working Length14.9 Inch
Device Size Text, specify0

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.
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.
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
GS105708932279932 [Package]
Contains: 05708932999342
Package: Retail box [30 Units]
In Commercial Distribution
GS105708932279949 [Package]
Package: Shipper box [12 Units]
In Commercial Distribution
GS105708932999342 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

On-Brand Devices [Self Cath]

05708932278614Self-Cath. Urinary Catheter. Straight Tip Female. FR 12. 6 in. 16 cm Rx only.
05708932278638Self-Cath. Urinary Catheter. Straight Tip Female. FR 14. 6 in. 16 cm Rx only.
05708932278683Self-Cath. Urinary Catheter. Luer End Pediatric. FR 10. 10 in. 25 cm Rx only.
05708932278713Self-Cath. Urinary Catheter. Straight Tip Male. FR 10. 16 in. 40 cm Rx only.
05708932278904Self-Cath. Urinary Catheter. Tapered Tip Coude w/Guide Stripe Male. FR 10. 16 in. 40 cm Rx only.
05708932279000Self-Cath. Urinary Catheter. Olive Tip Coude w/Guide Stripe Male. FR 6. 16 in. 40 cm Rx only.
05708932279031Self-Cath. Urinary Catheter. Olive Tip Coude w/Guide Stripe Male. FR 8. 16 in. 40 cm Rx only.
05708932279086Self-Cath. Urinary Catheter. Olive Tip Coude w/Guide Stripe Male. FR 14. 16 in. 40 cm Rx only.
05708932279802Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Straight Tip. Male. FR 18. 16 in. 40 cm. Rx
05708932279826Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Tapered Tip Coude w/Guide Stripe Male. FR 8
05708932279918Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Olive Tip Coude w/Guide Stripe. Male. FR 10
05708932279987Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Olive Tip Coude w/Guide Stripe. Male. FR 16
05708932278751Self-Cath. Urinary Catheter. Straight Tip Male. FR 16. 16 in. 40 cm Rx only.
05708932278942Self-Cath. Urinary Catheter. Tapered Tip Coude w/Guide Stripe Male. FR 14. 16 in. 40 cm
05708932277150Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Straight Tip. Female. FR 10. 6 in. 16 cm. R
05708932279833Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Tapered Tip Coude w/Guide Stripe. Male. FR
05708932279888Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Tapered Tip Coude w/Guide Stripe. Male. FR
05708932279895Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Olive Tip Coude w/Guide Stripe. Male. FR 8.
05708932279932Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Olive Tip Coude w/Guide Stripe. Male. FR 12
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