AccessGUDID - DEVICE: 7 Fr. Ureteral catheter (10854913006058)

GUDID

Device Identifier (DI) Information

Brand Name: 7 Fr. Ureteral catheter
Version or Model: Ureteral catheter
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: UROGEN PHARMA LTD

Primary DI Number: 10854913006058
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 534155213 *Terms of Use

Device Description: No description.

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":	No
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?
34926	Ureteral catheter	A flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOD	Catheter, Urological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180354	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Length: 70 Centimeter
Catheter Gauge: 7 French

Device Record Status

Public Device Record Key: 209544db-48c4-4444-8561-41ca3180da20
Public Version Date: April 22, 2020
Public Version Number: 4
DI Record Publish Date: February 11, 2019