Guideline 4000™ 5.0 C0217

GUDID 00873263006795

MicroTargeting Guidline 4000 5.0 Software 1x

FHC, INC.

Neurophysiologic monitoring system
Primary Device ID00873263006795
NIH Device Record Key7d0566fd-0cb9-4c6b-aff1-a14a5df97d99
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuideline 4000™ 5.0
Version Model NumberC0217-00679
Catalog NumberC0217
Company DUNS108179458
Company NameFHC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
Emailfhcinc@fh-co.com

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100873263006795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLELECTRODE, DEPTH

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-19
Device Publish Date2019-01-02

On-Brand Devices [Guideline 4000™ 5.0]

00873263006856Guideline 4000(TM) 5.0
00873263006795MicroTargeting Guidline 4000 5.0 Software 1x
00873263006757GL5 Notebook Computer
00873263006740GL5 Main Processing Unit

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.