Duns Number:362747011
Device Description: Humphrey Matrix is an AC-powered device intended to determine the extent of the peripheral Humphrey Matrix is an AC-powered device intended to determine the extent of the peripheral visual field of a patient. The device is intended to determine the amount of visual field loss in a patient, which can then be used to diagnose/track the progression of glaucoma and other eye diseases.
Catalog Number
-
Brand Name
Humphrey Matrix
Version/Model Number
800
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
3fe5104d-c97b-4413-b185-2db257461308
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 |