AccessGUDID - DEVICE: GentleYAG HR Delivery System W/DCD (00817495021652)

GUDID

Device Identifier (DI) Information

Brand Name: GentleYAG HR Delivery System W/DCD
Version or Model: 0800-00-1051
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Candela Corporation

Primary DI Number: 00817495021652
Issuing Agency: GS1
Commercial Distribution End Date: May 20, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 053468385 *Terms of Use

Device Description: Delivery System Assembly

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?
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 [?]
K140122	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: e40a0c1b-da5c-4688-8a31-8ab34fbbdd8c
Public Version Date: May 21, 2024
Public Version Number: 7
DI Record Publish Date: September 23, 2016