Bristle needles

GUDID 86573000022001

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

AP MEDESTHETICS, INC.

Intracutaneous electrosurgical probe Intracutaneous electrosurgical probe

• Primary Device ID: 86573000022001
• NIH Device Record Key: 32df6225-f25e-46e2-9f88-8af270ad134e
• Commercial Distribution Status: 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	86573000022001 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-18
• Device Publish Date: 2019-01-17

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