AccessGUDID - DEVICE: PURE DentA (07290016814668)

GUDID

Device Identifier (DI) Information

Brand Name: PURE DentA
Version or Model: PURE DentA 110V
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ND_PRD00480-00
Company Name: ENDYMED MEDICAL LTD

Primary DI Number: 07290016814668
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531958689 *Terms of Use

Device Description: The ENDYMED PURE DentA is a device intended for use in Dermatologic and General Surgical Procedures.

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
OUH	Skin Resurfacing Rf Applicator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120513	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: b20eabaf-f2d0-4391-b210-703139f7201e
Public Version Date: November 14, 2024
Public Version Number: 1
DI Record Publish Date: November 06, 2024