MicroTargeting™ RPD Adapter C0254

GUDID 00873263007396

3.3mm RPD Adapter

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263007396
• NIH Device Record Key: ae61fc8e-f276-4509-b1bd-6d2f97b1a600
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroTargeting™ RPD Adapter
• Version Model Number: C0254-00730
• Catalog Number: C0254
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com

Device Dimensions

• Lumen/Inner Diameter: 3.41 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263007303 [Primary]
GS1	00873263007396 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092192

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00873263007396]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-09
• Device Publish Date: 2020-02-29

On-Brand Devices [MicroTargeting™ RPD Adapter]

• 00873263007402: 2.2 mm RPD Adapter
• 00873263007396: 3.3mm RPD Adapter