AccessGUDID - DEVICE: SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III (00817495024455)

GUDID

Device Identifier (DI) Information

Brand Name: SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III
Version or Model: AS87512
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS87512
Company Name: Candela Corporation

Primary DI Number: 00817495024455
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053468385 *Terms of Use
Previous DI: 07290109952703

Device Description: SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III

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?
44832	Multi-modality skin contouring system	An assembly of devices that uses a combination of energies to temporarily minimize the manifestation of cellulite and loose or wrinkled skin. It typically consists of an applicator attached to an energy-producing generator and possibly other components. The applicator is applied to the body and may emit radio-frequency [typically in the bands of 1 megahertz (MHz)], infrared light, and/or other forms of energy, to heat skin/subdermal tissues for the production of a smooth-skin appearance. Vacuum may also be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

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: 95b98b06-916d-47f9-89c2-44e04ed27630
Public Version Date: November 13, 2023
Public Version Number: 2
DI Record Publish Date: October 20, 2023