Dophi

Basic Information

• Brand Name: Dophi
• Primary DI: 16972304750015
• Version / Model: SS-TP18G-20
• Company Name: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
• Labeler DUNS: 550274579
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-19
• Public Version: 2
• Public Version Date: 2023-10-30
• Public Version Status: Update
• Public Device Record Key: 90833d65-cea6-4cda-9cc1-4ad5a12ac41f

Device Description

Temperature Probe

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	16972304750015	GS1

Premarket Submissions

Submission Number	Supplement Number
K183153	000