STar™ Drive Electrode Carrier FC8008

GUDID 00873263008331

STar™ Drive Locking Array Electrode Carrier

FHC, INC.

Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive

• Primary Device ID: 00873263008331
• NIH Device Record Key: 5bf3f79e-ad08-4d36-aa8b-8193dccecd8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STar™ Drive Electrode Carrier
• Version Model Number: FC8008-00833
• Catalog Number: FC8008
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• 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	00873263008331 [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

[00873263008331]

Moist Heat or Steam Sterilization

[00873263008331]

Moist Heat or Steam Sterilization

[00873263008331]

Moist Heat or Steam Sterilization

[00873263008331]

Moist Heat or Steam Sterilization

[00873263008331]

Moist Heat or Steam Sterilization

[00873263008331]

Moist Heat or Steam Sterilization

[00873263008331]

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