AccessGUDID - DEVICE: Urethral Warming Catheter Kit (00810563020977)

GUDID

Device Identifier (DI) Information

Brand Name: Urethral Warming Catheter Kit
Version or Model: DP40-0141-106
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CRYO-77
Company Name: VARIAN MEDICAL SYSTEMS, INC.

Primary DI Number: 00810563020977
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009120817 *Terms of Use

Device Description: Urethral Warming catheter for use in tissue warmning during cryosurgical procedures with the Cryocare systems

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	No
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?
45140	Cryosurgical set	A sterile collection of disposable devices used in conjunction with a cryosurgical unit as well as monitoring and other devices to perform a surgical technique that involves freezing a targeted area of tissue to damage and destroy cancer cells in the unwanted portions. A typical set will contain cryo needles, thermal sensors, warmer tubes and catheters, warmer cassette, and tube holders. It is typically used for early stages of prostate cancer or late recurrence of localized prostate cancer after radiotherapy where the prostate is cooled to a temperature of -40Â° Celsius. Warming of the areas where freezing is not required is simultaneously carried out. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEH	UNIT, CRYOSURGICAL, ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211149	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
No Device Sizes

Device Record Status

Public Device Record Key: e13d44ed-ba25-4597-b7fb-c7e97a5d4b37
Public Version Date: October 02, 2023
Public Version Number: 2
DI Record Publish Date: February 03, 2022