Bristle needles

GUDID 28657300002201

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.

AP MEDESTHETICS, INC.

Intracutaneous electrosurgical probe

• Primary Device ID: 28657300002201
• NIH Device Record Key: 2e4e9d00-7722-4511-8089-22dc51850317
• Commercial Distribution Discontinuation: 2019-11-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Bristle needles
• Version Model Number: 27G, 33G
• Company DUNS: 056296605
• Company Name: AP MEDESTHETICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	28657300002201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112426

FDA Product Code

• GXZ: Electrode, Needle

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-01
• Device Publish Date: 2019-06-10

On-Brand Devices [Bristle needles]

• 86573000022001: The single piece device is a plastic handle fused to a stainless-steel needle, insulated to the
• 18657300002204: The single piece device is a plastic handle fused to a stainless-steel needle, insulated to the
• 28657300002201: The single piece device is a plastic handle fused to a stainless-steel needle, insulated to the