AccessGUDID - DEVICE: Porges Coloplast (03600040322666)

GUDID

Device Identifier (DI) Information

Brand Name: Porges Coloplast
Version or Model: ASXL10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ASXL10
Company Name: Coloplast A/S

Primary DI Number: 03600040322666
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: RETRACE® Ureteral Access Sheath, inner diameter CH FR 10, outer diameter CH FR 12, length 28 cm

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:	No
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?
64309	Ureteral introduction sheath	A flexible tube intended to be used for ureteral access to allow introduction of other instruments (e.g., endoscope, catheter) and/or for guidewire exchange during a urological procedure. It may be intended for ureteral access via transurethral and/or percutaneous approach, and typically includes an inner dilator; it is however not a full introduction set. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FED	endoscopic access overtube, gastroenterology-urology

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: 10 French
Catheter Gauge: 12 French

Device Record Status

Public Device Record Key: b31f47f8-28c3-40fd-8262-cefd5b018165
Public Version Date: March 20, 2024
Public Version Number: 3
DI Record Publish Date: July 16, 2019