AccessGUDID - DEVICE: Hand Piece Internal, Packaged, CO2RE Intima (07290109950730)

GUDID

Device Identifier (DI) Information

Brand Name: Hand Piece Internal, Packaged, CO2RE Intima
Version or Model: AS89731
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS89731
Company Name: SYNERON MEDICAL LTD

Primary DI Number: 07290109950730
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532685716 *Terms of Use

Device Description: Hand Piece Internal, Packaged, CO2RE Intima

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:	Yes
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Dermatological carbon dioxide laser system	A mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam [i.e., not considered low-level laser therapy (LLLT)], intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, scar treatment, skin tightening, and lesion/hair/tattoo removal. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch.

GMDN Preferred Term Name

GMDN Definition

Dermatological carbon dioxide laser system

A mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam [i.e., not considered low-level laser therapy (LLLT)], intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, scar treatment, skin tightening, and lesion/hair/tattoo removal. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch.

FDA Product Code

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Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151655	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 3fb83a30-4d5f-465b-899f-84c3fbd3876a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 26, 2016