SureCath 28036

GUDID 05708932615884

SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic coated catheter. Nelaton. Male. FR 14/4.7 mm. Vol 1200

Coloplast A/S

Single-administration urethral catheterization kit, single-use
Primary Device ID05708932615884
NIH Device Record Key06361dbb-ac8d-41d3-a414-3e44e40e2f26
Commercial Distribution StatusIn Commercial Distribution
Brand NameSureCath
Version Model Number28036
Catalog Number28036
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 Latexfalse
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

Device Dimensions

Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter
Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter
Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter
Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter
Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter
Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter
Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter
Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter
Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter
Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter
Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter
Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter
Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter
Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter
Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter
Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter
Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter
Outer Diameter4.7 Millimeter
Catheter Gauge14 French
Device Size Text, specify0
Length40 Centimeter
Total Volume1200 Milliliter

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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 sterile barrier is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS105708932021487 [Primary]
GS105708932615785 [Package]
Contains: 05708932021487
Package: Retail box [20 Units]
In Commercial Distribution
GS105708932615884 [Package]
Contains: 05708932615785
Package: Shipper box [4 Units]
In Commercial Distribution

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 Date2016-09-02

On-Brand Devices [SureCath]

05708932640633SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932640640SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932640671SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932640664SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932615884SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932640619SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932640596SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932640343SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932640336SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932639835SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932640428SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932640411SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932640404SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932640381SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932640367SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932640350SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932639828SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932639804SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932639798SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932639781SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932639774SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
05708932639767SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic

Trademark Results [SureCath]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SURECATH
SURECATH
75767233 2476472 Live/Registered
Coloplast A/S
1999-08-03
SURECATH
SURECATH
73673722 1574606 Dead/Cancelled
TITAN MEDICAL INC.
1987-07-22

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