STar™ Drive XL Frame Adapter 70-FA-RD-XL

GUDID 00873263002063

STar(TM) Drive XL Frame Adapter for use with Radionics CRW stereotactic frame

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 00873263002063
• NIH Device Record Key: 84c06e52-6fe6-4b58-ae48-5105e5271d17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STar™ Drive XL Frame Adapter
• Version Model Number: 70-FA-RD-XL-00225
• Catalog Number: 70-FA-RD-XL
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263002063 [Direct Marking]
GS1	00873263002254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121950

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00873263002063]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-17

On-Brand Devices [STar™ Drive XL Frame Adapter]

• 00873263002049: XL STar(TM) Leksell Stereotactic System(R) Adapter
• 00873263002063: STar(TM) Drive XL Frame Adapter for use with Radionics CRW stereotactic frame