Duns Number:126650253
Device Description: Ten (10) replacement tip and membrane assemblies that attach to the Model 30 Pneumatonomet Ten (10) replacement tip and membrane assemblies that attach to the Model 30 Pneumatonometer probe. Probe tip touches a patient's cornea during the measurement.
Catalog Number
-
Brand Name
Model 30™ Tip and Membrane Assembly for Pneumatonometer
Version/Model Number
230678
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
HKX
Product Code Name
Tonometer, Ac-Powered
Public Device Record Key
528eec58-5a74-4a23-b2c9-24212c87f53c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 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. | 22 |