STar™ Drive Electrode Carrier FC8010

GUDID 00873263008348

STar™ Drive Single Electrode Insertion Locking Carrier, 2x, can also be used with the microTargeting(TM) Drive

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 00873263008348
• NIH Device Record Key: a49edf49-fd53-48a7-b8a9-b5f3daef103b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STar™ Drive Electrode Carrier
• Version Model Number: FC8010-00834
• Catalog Number: FC8010
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 2
• DM Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263008348 [Unit of Use]
GS1	10873263008345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092562

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00873263008348]

Moist Heat or Steam Sterilization

[00873263008348]

Moist Heat or Steam Sterilization

[00873263008348]

Moist Heat or Steam Sterilization

[00873263008348]

Moist Heat or Steam Sterilization

[00873263008348]

Moist Heat or Steam Sterilization

[00873263008348]

Moist Heat or Steam Sterilization

[00873263008348]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-09
• Device Publish Date: 2021-07-30

On-Brand Devices [STar™ Drive Electrode Carrier]

• 00873263006962: Single Electrode Carrier
• 00873263002841: STar(TM) Drive Array Electrode Carrier
• 00873263000830: STar(TM) Drive Locking Array Electrode Carrier
• 10873263002909: Single Electrode Carriers, 2x, non-sterile
• 00873263008348: STar™ Drive Single Electrode Insertion Locking Carrier, 2x, can also be used with the microTar
• 00873263008331: STar™ Drive Locking Array Electrode Carrier