AccessGUDID - DEVICE: Bristle needles (18657300002204)

GUDID

Device Identifier (DI) Information

Brand Name: Bristle needles
Version or Model: 27G, 33G
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: AP MEDESTHETICS, INC.

Primary DI Number: 18657300002204
Issuing Agency: GS1
Commercial Distribution End Date: November 27, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 056296605 *Terms of Use

Device Description: The single piece device is a plastic handle fused to a stainless-steel needle, insulated to the tip. The other end of the plastic handle is fused to a flexible lead wire and a “touch-proof” safety connector. The device is used to transfer RF energy from the VeinGogh generator to the spider vein.

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?
63686	Intradermal radio-frequency ablation system probe	A hand-held surgical instrument intended to be introduced into the dermal layer of the skin (intradermal) to deliver radio-frequency current in a monopolar configuration from a system generator for coagulation/ablation to treat skin conditions [typically superficial skin lesions (e.g., telangiectasia, cherry angioma, venous lake, skin tags) and/or acne]. It is comprised of an insulated handle with a thin, distal, monopolar electrode. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXZ	Electrode, Needle

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 89c6962c-9349-4d63-8d90-6ff57d9f2f52
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: June 06, 2019