AccessGUDID - DEVICE: Porges Coloplast (03600040203811)

GUDID

Device Identifier (DI) Information

Brand Name: Porges Coloplast
Version or Model: AJ4W86
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AJ4W86
Company Name: Coloplast A/S

Primary DI Number: 03600040203811
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: STENOSTENT ® double loop ureteral stent in silicone open/open with total reinforcement CH FR 08/12 length 30 cm with connectable pusher and fixed core guidewire

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58005	Polymeric ureteral stent	A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. The device is typically intended for long-term, but not permanent, implantation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FAD	STENT, URETERAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store away from light in a cool and dry place

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 12 French
Length: 30 Centimeter

Device Record Status

Public Device Record Key: 79c1971e-d3cf-4826-bcd8-9fcdbde80889
Public Version Date: April 03, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2015