STar™ Drive Frame Adapter 70-FA-BL

GUDID 00873263002353

STar(TM) Drive Frame Adapter for use with Brain Lab(R)/Micromar stereotactic frames

FHC, INC.

Neurosurgical micro targeting drive

Primary Device ID	00873263002353
NIH Device Record Key	725b31cf-b0b5-4a91-85cb-2cc07689ff1b
Commercial Distribution Status	In Commercial Distribution
Brand Name	STar™ Drive Frame Adapter
Version Model Number	70-FA-BL-00235
Catalog Number	70-FA-BL
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	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
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 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	00873263002353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K092562

FDA Product Code

HAW	Neurological stereotaxic Instrument