Porges Coloplast BCFM64

GUDID 05708932063210

VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 06 length 26 cm with steerable pusher and fixed core guidewire and Flush uret

Coloplast A/S

Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent
Primary Device ID05708932063210
NIH Device Record Key6934a8c5-145f-4a06-8a19-df986e29fbeb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePorges Coloplast
Version Model NumberBCFM64
Catalog NumberBCFM64
Company DUNS305524696
Company NameColoplast A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com
Phone+1(800)258-3476
Emailurology@coloplast.com

Device Dimensions

Length26 Centimeter
Catheter Gauge6 French
Length26 Centimeter
Catheter Gauge6 French
Length26 Centimeter
Catheter Gauge6 French
Length26 Centimeter
Catheter Gauge6 French
Length26 Centimeter
Catheter Gauge6 French
Length26 Centimeter
Catheter Gauge6 French
Length26 Centimeter
Catheter Gauge6 French
Length26 Centimeter
Catheter Gauge6 French
Length26 Centimeter
Catheter Gauge6 French
Length26 Centimeter
Catheter Gauge6 French
Length26 Centimeter
Catheter Gauge6 French
Length26 Centimeter
Catheter Gauge6 French
Length26 Centimeter
Catheter Gauge6 French
Length26 Centimeter
Catheter Gauge6 French
Length26 Centimeter
Catheter Gauge6 French
Length26 Centimeter
Catheter Gauge6 French
Length26 Centimeter
Catheter Gauge6 French
Length26 Centimeter
Catheter Gauge6 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light in a cool and dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS105708932063210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FADSTENT, URETERAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-05

On-Brand Devices [Porges Coloplast]

10884450143343ORCHESTRA® Hydrophilic guidewire, angled, stiff, 3 cm flexible tip
10884450143329ORCHESTRA® Hydrophilic guidewire, angled, standard, 3 cm flexible tip
10884450143312ORCHESTRA® Hydrophilic guidewire, straight, standard, 3 cm flexible tip
10884450143299ORCHESTRA® Hydrophilic guidewire, straight, stiff, 3 cm flexible tip
05708932681087VORTEK® Double loop ureteral stent open/open CH FR 4.8 length 28 cm with steerable pusher CH FR
05708932065252VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 07 length 28 cm with n
05708932065221VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 07 length 26 cm with n
05708932065191VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 06 length 28 cm with n
05708932065160VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 06 length 26 cm with n
05708932065139VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 4.8 length 28 cm with
05708932065108VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 4.8 length 26 cm with
05708932065078BIOSOFT® Duo Double loop ureteral stent open/open CH FR 08 length 28 cm with fixed core guidewi
05708932065047BIOSOFT® Duo Double loop ureteral stent open/open CH FR 08 length 26 cm with fixed core guidewi
05708932065016BIOSOFT® Duo Double loop ureteral stent open/open CH FR 07 length 28 cm with fixed core guidewi
05708932064989BIOSOFT® Duo Double loop ureteral stent open/open CH FR 07 length 26 cm with fixed core guidewi
05708932064958BIOSOFT® Duo Double loop ureteral stent open/open CH FR 07 length 24 cm with fixed core guidewi
05708932064927BIOSOFT® Duo Double loop ureteral stent open/open CH FR 06 length 28 cm with fixed core guidewi
05708932064897BIOSOFT® Duo Double loop ureteral stent open/open CH FR 06 length 26 cm with fixed core guidewi
05708932064866BIOSOFT® Duo Double loop ureteral stent open/open CH FR 06 length 24cm with fixed core guidewir
05708932064477VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 07 length 22 cm with s
05708932064446VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 07 length 30 cm with s
05708932064415VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 07 length 28 cm with s
05708932064385VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 07 length 26 cm with s
05708932064354VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 07 length 24 cm with s
05708932064323VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 06 length 22 cm with s
05708932064293VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 06 length 30 cm with s
05708932064262VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 06 length 28 cm with s
05708932064231VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 06 length 26 cm with s
05708932064200VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 06 length 24 cm with s
05708932064170VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 4.8 length 22 cm with
05708932064149VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 4.8 length 28 cm with
05708932064118VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 4.8 length 26 cm with
05708932064088VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 4.8 length 24 cm with
05708932064057VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 4.8 length 22 cm with
05708932064026VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 4.8 length 28 cm with
05708932063999VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 4.8 length 26 cm with
05708932063968VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 4.8 length 24 cm with
05708932063937VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 07 length 22 cm with s
05708932063906VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 07 length 30 cm with s
05708932063876VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 07 length 28 cm with s
05708932063845VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 07 length 26 cm with s
05708932063814VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 07 length 24 cm with s
05708932063784VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 06 length 22 cm with s
05708932063753VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 06 length 30 cm with s
05708932063722VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 06 length 28 cm with s
05708932063692VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 06 length 26 cm with s
05708932063661VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 06 length 24 cm with s
05708932063630VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 4.8 length 22 cm with
05708932063609VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 4.8 length 28 cm with
05708932063579VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 4.8 length 26 cm with

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