FDA UDI In Commercial Distribution 🇺🇸 United States

Porges Coloplast

DI: 05708932063005 · Model: BCFD67 · Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Basic Information

Brand Name
Porges Coloplast
Primary DI
05708932063005
Version / Model
BCFD67
Catalog Number
BCFD67
Company Name
Coloplast A/S
Labeler DUNS
305524696
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-04-05
Public Version
3
Public Version Date
2024-01-08
Public Version Status
Update
Public Device Record Key
75d9575d-0c02-4f5c-ab0e-0ae46a96ff54

Device Description

VORTEK® Double loop ureteral stent with hydrogel coating open/open CH FR 06 length 22 cm with steerable pusher

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
MR Safe
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FAD STENT, URETERAL

GMDN Terms

Code Name
58005 Polymeric ureteral stent

Identifiers

Type ID
Primary 05708932063005

Customer Contacts

Device Sizes

Type Value Unit Text
Length 22 Centimeter
Catheter Gauge 6 French

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
Store away from light in a cool and dry place