Ablation Platform Mounting Hardware C0257

GUDID 00873263007334

Platform Attachment Set

FHC, INC.

Neurological stereotactic surgery system
Primary Device ID00873263007334
NIH Device Record Key5b2e78a2-092a-44b1-a0af-071999f9bb2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAblation Platform Mounting Hardware
Version Model NumberC0257-00733
Catalog NumberC0257
Company DUNS108179458
Company NameFHC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100873263007334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00873263007334]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-25
Device Publish Date2020-03-17

Devices Manufactured by FHC, INC.

00873263007334 - Ablation Platform Mounting Hardware2020-03-25Platform Attachment Set
00873263007334 - Ablation Platform Mounting Hardware2020-03-25 Platform Attachment Set
00873263007419 - MicroTargeting™ Sterilization Basket2020-03-09 Small Parts Sterilization Basket, 1x
00873263007402 - MicroTargeting™ RPD Adapter2020-03-09 2.2 mm RPD Adapter
00873263007396 - MicroTargeting™ RPD Adapter2020-03-09 3.3mm RPD Adapter
00873263007877 - Waypoint™ Navigator2020-03-05 Waypoint™ Navigator -Academic License
00873263007860 - Waypoint™ Navigator2020-03-05 Waypoint™ Navigator -Pay-per-use License
00873263007853 - Waypoint™ Navigator2020-03-05 Waypoint™ Navigator - Enterprise License
00873263001868 - microTargeting™ Frame Adapter2020-02-24 Leksell Offsetting Adapter for use with microTargeting Drive

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