Duns Number:809555139
Device Description: Osher-Neumann Corneal Marker 8 Blade, Diamond knurled handle, 118mm total length, Stainles Osher-Neumann Corneal Marker 8 Blade, Diamond knurled handle, 118mm total length, Stainless
Catalog Number
M20-8
Brand Name
Diamatrix Ltd.
Version/Model Number
M20-8
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
HNQ
Product Code Name
Hook, Ophthalmic
Public Device Record Key
d792d9c2-a743-4e9f-9e1c-bdcac9ec0093
Public Version Date
September 20, 2022
Public Version Number
1
DI Record Publish Date
September 12, 2022
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 | 475 |
U | Unclassified | 13 |