AccessGUDID - DEVICE: 5-Pk, external hygienic, CO2RE Intima (00817495024400)

GUDID

Device Identifier (DI) Information

Brand Name: 5-Pk, external hygienic, CO2RE Intima
Version or Model: KT76685
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KT76685
Company Name: Candela Corporation

Primary DI Number: 00817495024400
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053468385 *Terms of Use

Device Description: 5-Pk, external hygienic, 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: 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: a1fe4bc5-4385-46e4-ad92-12c210db6a7b
Public Version Date: October 15, 2024
Public Version Number: 2
DI Record Publish Date: October 20, 2023