Visualase MR Stiffening Stylet 9736538

GUDID 00873263009338

Visualase MR Stiffening Stylet (1) MR Stiffening Stylet

FHC, INC.

Neurological stereotactic surgery system
Primary Device ID00873263009338
NIH Device Record Key36d287e9-d2fb-4698-abb1-ed1043a3db33
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisualase MR Stiffening Stylet
Version Model Number9736538-00933
Catalog Number9736538
Company DUNS108179458
Company NameFHC, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100873263009338 [Primary]

FDA Product Code

GAHSTYLET, SURGICAL, GENERAL & PLASTIC SURGERY

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00873263009338]

Ethylene Oxide


[00873263009338]

Ethylene Oxide


[00873263009338]

Ethylene Oxide


[00873263009338]

Ethylene Oxide


[00873263009338]

Ethylene Oxide


[00873263009338]

Ethylene Oxide


[00873263009338]

Ethylene Oxide


[00873263009338]

Ethylene Oxide


[00873263009338]

Ethylene Oxide


[00873263009338]

Ethylene Oxide


[00873263009338]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-22
Device Publish Date2025-12-12

On-Brand Devices [Visualase MR Stiffening Stylet]

00873263009079Visualase MR Stiffening Stylet (1) MR Stiffening Stylet
00873263009338Visualase MR Stiffening Stylet (1) MR Stiffening Stylet

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.