STar™ Drive Frame Adapter 70-FA-RD-01

GUDID 00873263002070

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

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

• Primary Device ID: 00873263002070
• NIH Device Record Key: 6c8e5c15-fdab-426d-a629-b79bbab02732
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STar™ Drive Frame Adapter
• Version Model Number: 70-FA-RD-01-00224
• Catalog Number: 70-FA-RD-01
• 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
• 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
• 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
• 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 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263002070 [Direct Marking]
GS1	00873263002247 [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

[00873263002070]

Moist Heat or Steam Sterilization

[00873263002070]

Moist Heat or Steam Sterilization

[00873263002070]

Moist Heat or Steam Sterilization

[00873263002070]

Moist Heat or Steam Sterilization

[00873263002070]

Moist Heat or Steam Sterilization

[00873263002070]

Moist Heat or Steam Sterilization

[00873263002070]

Moist Heat or Steam Sterilization

[00873263002070]

Moist Heat or Steam Sterilization

[00873263002070]

Moist Heat or Steam Sterilization

[00873263002070]

Moist Heat or Steam Sterilization

[00873263002070]

Moist Heat or Steam Sterilization

[00873263002070]

Moist Heat or Steam Sterilization

[00873263002070]

Moist Heat or Steam Sterilization

[00873263002070]

Moist Heat or Steam Sterilization

[00873263002070]

Moist Heat or Steam Sterilization

[00873263002070]

Moist Heat or Steam Sterilization

[00873263002070]

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 Frame Adapter]

• 00873263006191: STar™ Frame Adapter-General Purpose, 1X
• 00873263002018: STar(TM) Drive Frame Adapter for use with Brain Lab(R)/Micromar stereotactic frames
• 00873263002025: STar(TM) Drive Frame Adapter for use with Leksell Stereotactic Frame
• 00873263002032: STar(TM) Drive Offseting Frame Adapter for use with Leksell Stereotactic Frame
• 00873263002056: STar(TM) Drive Frame Adapter for use with Radionics CRW stereotactic frame
• 00873263002070: STar(TM) Drive Offseting Frame Adapter for use with Radionics CRW(TM) stereotactic frame
• 00873263002087: STar(TM) Drive Frame Adapter for use with Leibinger RM stereotactic frame
• 00873263002117: STar(TM) Drive Frame Adapter for use with Leibinger ZD stereotactic frame
• 00873263001608: STar(TM) Drive Frame Adapter for use with Leibinger ZD stereotactic frame
• 00873263001592: STar(TM) Drive Frame Adapter for use with Leibinger RM stereotactic frame
• 00873263001585: STar(TM) Drive Frame Adapter for use with Radionics CRW stereotactic frame
• 00873263001622: STar(TM) Drive Frame Adapter for use with Leskell stereotactic frame
• 00873263008539: STar™ Frame Adapter, 1x for Leksell Stereotactic System® 1.6 mm
• 00873263002353: STar(TM) Drive Frame Adapter for use with Brain Lab(R)/Micromar stereotactic frames