Duns Number:362747011
Device Description: Humphrey FDT is an AC-powered device intended to determine the extent of the peripheralvis Humphrey FDT is an AC-powered device intended to determine the extent of the peripheralvisual field of a patient. The device is intended to determine the amount of visual field lossin a patient, which can then be used to diagnose/track the progression of glaucoma andother eye diseases.
Catalog Number
-
Brand Name
Humphrey FDT
Version/Model Number
710
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 13, 2018
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HOO
Product Code Name
Perimeter, Ac-Powered
Public Device Record Key
92630dd0-2fd2-4f9e-ae55-4b31605205f2
Public Version Date
July 16, 2018
Public Version Number
1
DI Record Publish Date
June 13, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |