Duns Number:015272206
Device Description: Allen-Schiotz tonometer with Plunger Retractor and inclined scale, manufactured and certif Allen-Schiotz tonometer with Plunger Retractor and inclined scale, manufactured and certified by Gulden Ophthalmics, supplied with case, tables, zero test block and 5.5, 7.5, 10 and 15 gram weights
Catalog Number
5757E
Brand Name
Ambler Surgical
Version/Model Number
5757E
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
K945541
Product Code
HKY
Product Code Name
Tonometer, manual
Public Device Record Key
11ee7547-19aa-4c48-9758-2b38f839d363
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 29, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |