AccessGUDID - DEVICE: External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima (00817495024554)

GUDID

Device Identifier (DI) Information

Brand Name: External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
Version or Model: KT77911
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KT77911
Company Name: Candela Corporation

Primary DI Number: 00817495024554
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053468385 *Terms of Use
Previous DI: 17290109952823

Device Description: External Handpiece 5-Pack Sterile Single-Use, 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?
45221	Dermatological laser beam guiding handpiece	A hand-held component of a dermatological laser system designed to conduct a therapeutic laser (e.g., solid state laser) from the laser generator to the treatment site for ablative and non-ablative treatment of the skin (e.g., removal of pigment/vascular lesions, scarring, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). This is a reusable device.	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: df41653a-54f1-42ec-ba02-bd40bd06de76
Public Version Date: October 30, 2023
Public Version Number: 1
DI Record Publish Date: October 20, 2023