AccessGUDID - DEVICE: Hand Piece, external, Packaged, CO2RE Intima (07290109950747)

GUDID

Device Identifier (DI) Information

Brand Name: Hand Piece, external, Packaged, CO2RE Intima
Version or Model: AS90242
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AS90242
Company Name: SYNERON MEDICAL LTD

Primary DI Number: 07290109950747
Issuing Agency: GS1
Commercial Distribution End Date: October 16, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 532685716 *Terms of Use

Device Description: Hand Piece, external, 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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61473	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, 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181523	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: 5c89b496-9ce4-4a3b-9aff-bfdd1a104735
Public Version Date: October 17, 2023
Public Version Number: 7
DI Record Publish Date: September 26, 2016