Duns Number:015272206
Device Description: Schiotz tonometer weight - 5.5 gram, must send entire unit in for service when ordering th Schiotz tonometer weight - 5.5 gram, must send entire unit in for service when ordering this replacement part, service charge included in price listed
Catalog Number
5758E
Brand Name
Ambler Surgical
Version/Model Number
5758E
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
c5007531-fec0-4798-8a1e-f9d194fe21ef
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 |