Humphrey FDT

GUDID 04057748085215

Humphrey FDT is an AC-powered device intended to determine the extent of the peripheral visual field of a patient. The device is intended to determine

Carl Zeiss Meditec, Inc.

Perimeter, automatic
Primary Device ID04057748085215
NIH Device Record Key92630dd0-2fd2-4f9e-ae55-4b31605205f2
Commercial Distribution Discontinuation2018-06-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHumphrey FDT
Version Model Number710
Company DUNS362747011
Company NameCarl Zeiss Meditec, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104057748085215 [Primary]

FDA Product Code

HOOPerimeter, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-16
Device Publish Date2018-06-13

Devices Manufactured by Carl Zeiss Meditec, Inc.

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