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

• 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
• 00873263008324: STar™ Drive Frame Adapter for use with Leibinger ZD stereotactic frame
• 00873263008317: STar™ Drive Frame Adapter for use with Leibinger RM stereotactic frame
• 00873263008300: STar™ Drive Frame Adapter for use with Radionics CRW stereotactic frame
• 00873263002261: STar(TM) Drive Frame Adapter for use with Radionics CRW stereotactic frame
• 00873263002223: STar(TM) Drive Frame Adapter for use with Leibinger RM stereotactic frame
• 00873263002193: STar(TM) Drive Frame Adapter for use with Leibinger ZD stereotactic frame