33 cm Lead Insertion Tube Set FC1023

GUDID 10873263008208

33 cm Lead Insertion Tube Set, for microTargeting STar Drive

FHC, INC.

Intracerebral cannula, nonimplantable, single-use

Primary Device ID	10873263008208
NIH Device Record Key	8debdf9b-bdee-4bf9-8102-45b022bc994d
Commercial Distribution Status	In Commercial Distribution
Brand Name	33 cm Lead Insertion Tube Set
Version Model Number	FC1023-00820
Catalog Number	FC1023
Company DUNS	108179458
Company Name	FHC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
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
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 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Handling Environment Humidity	Between 0 Degrees Celsius and 95 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263008201 [Primary]
GS1	10873263008208 [Package] Contains: 00873263008201 Package: PK/5 [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K011775

FDA Product Code

HAW	Neurological stereotaxic Instrument