Passive Headrest Accessories PH-2510

GUDID 00873263007778

PH-2510 Passive Headrest Accessories

FHC, INC.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system

Primary Device ID	00873263007778
NIH Device Record Key	c86bfae2-37cb-4f91-bc78-4f06a22af3e8
Commercial Distribution Discontinuation	2024-03-11
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Passive Headrest Accessories
Version Model Number	PH-2510-00777
Catalog Number	PH-2510
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	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
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263007778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K031885

FDA Product Code

HBL	HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2024-03-12
Device Publish Date	2020-11-13

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00873263002643 - STar™ Drive Lead Adapter	2024-05-22 DBS Lead Adapter for STar(TM) Drive
00873263002728 - STar™ Drive Lead Measurement Fixture	2024-05-22 DBS Lead Measurement Fixture for STar(TM) Drive for use with stereotactic frame
00873263002995 - STar™ Drive SteriSuite Case	2024-05-22 Sterilzation Wire Basket for STar(TM) Drive System