AccessGUDID - DEVICE: Dophi (16972304750015)

GUDID

Device Identifier (DI) Information

Brand Name: Dophi
Version or Model: SS-TP18G-20
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

Primary DI Number: 16972304750015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 550274579 *Terms of Use

Device Description: Temperature Probe

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?
65125	Cryosurgical system temperature probe	A hand-held device intended to be used to monitor tissue temperature during a cryosurgical procedure, typically to measure the temperature in tissue adjacent to the ablated zone to assess extent of ablation and to limit ablation to protect local tissues. It is in the form of a needle-like probe with a temperature sensor and proximal handle with a cable for connecting to the cryosurgical system control unit. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEY	System, Ablation, Microwave And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183153	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: 90833d65-cea6-4cda-9cc1-4ad5a12ac41f
Public Version Date: October 30, 2023
Public Version Number: 2
DI Record Publish Date: January 19, 2022