AccessGUDID - DEVICE: Ureteral Catheter Administration Kit (10854913006096)

GUDID

Device Identifier (DI) Information

Brand Name: Ureteral Catheter Administration Kit
Version or Model: UCAK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200006
Company Name: UROGEN PHARMA LTD

Primary DI Number: 10854913006096
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 534155213 *Terms of Use

Device Description: The Ureteral Catheter Administration Kit is designed for the convenience of the user for administration of gels or fluids into the urinary tract. The Ureteral Catheter Administration Kit contains: • Two (2) Syringe Adaptors • Two (2) Syringes, 20 mL • One (1) Ureteral Catheter, 7 Fr

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:	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?
60755	Urological surgical procedure kit, non-medicated, single-use	A collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHR	Catheter Care Tray

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 409d14a2-8ad6-4a9c-81c3-97c79f3513d1
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: May 17, 2020