Duns Number:010283033
Device Description: Indications for Use: Intraocular Pressure, Ocular Pulse Amplitude, Ophthalmodynamometry an Indications for Use: Intraocular Pressure, Ocular Pulse Amplitude, Ophthalmodynamometry and Tonography Measurement
Catalog Number
-
Brand Name
Falck Medical Multi-Function Applanation Tonometer
Version/Model Number
FMAT1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HKY
Product Code Name
Tonometer, Manual
Public Device Record Key
ff71fa08-5a8a-45e7-b27f-eb4a46767852
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 08, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |