AccessGUDID - DEVICE: truSculpt 2 RF handpiece (00816722022479)

GUDID

Device Identifier (DI) Information

Brand Name: truSculpt 2 RF handpiece
Version or Model: truSculpt 2 RF handpiece
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CUTERA, INC.

Primary DI Number: 00816722022479
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041071643 *Terms of Use

Device Description: truSculpt 2 cm^2 handheld handpiece for use with truSculpt iD RF device

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:	No
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?
45214	Radio-frequency skin contouring system applicator, monopolar	A monopolar handpiece that is part of a skin contouring system that uses radio-frequency (RF) energy to provide a capacitively coupled electrical connection for the transfer of radiated energy through a patient's skin in deep heat-mediated skin modification. The current passes from this device to an indifferent return electrode placed on the patient. This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories
PBX	Massager, Vacuum, Radio Frequency Induced Heat

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 34394142-e1b7-4da0-9fdc-7744a773b875
Public Version Date: November 22, 2022
Public Version Number: 1
DI Record Publish Date: November 14, 2022