AccessGUDID - DEVICE: Venus Viva applicator (07290016540482)

GUDID

Device Identifier (DI) Information

Brand Name: Venus Viva applicator
Version or Model: AS120070
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VENUS CONCEPT LTD

Primary DI Number: 07290016540482
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533127663 *Terms of Use

Device Description: RF applicator intended for dermatological procedures requiring ablation and resurfacing of the skin.

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?
45213	Radio-frequency skin contouring system applicator, bipolar	A bipolar 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 between the two tips of this device during treatment, and not through the patient to a return electrode. 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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153717	000

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: 88ab8f5c-1420-4963-9322-b7009dfc2597
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016