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 Intradermal electrosurgical probe Intradermal electrosurgical probe Intradermal electrosurgical probe Intradermal electrosurgical probe Intradermal electrosurgical probe Intradermal electrosurgical probe Intradermal electrosurgical probe Intradermal electrosurgical probe Intradermal electrosurgical probe Intradermal radio-frequency ablation system probe Intradermal radio-frequency ablation system probe Intradermal radio-frequency ablation system probe Intradermal radio-frequency ablation system probe Intradermal radio-frequency ablation system probe Intradermal radio-frequency ablation system 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