Duns Number:002373249
Device Description: Manual tonometer used to gauge internal pressure within the eye. An allen wrench can be us Manual tonometer used to gauge internal pressure within the eye. An allen wrench can be used to adjust weight settings.
Catalog Number
13110
Brand Name
Schioetz Tonometer - Allen Wrench Modification
Version/Model Number
13110
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K945541
Product Code
HKY
Product Code Name
Tonometer, Manual
Public Device Record Key
b686c1c6-4d60-4f46-a285-058627c3b629
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 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. | 24 |