Duns Number:079641356
Device Description: MARKER OPHTHALMIC 4.25IN 4.5MM OSHER NEUMANN CORNEAL RADIAL KERATOTOMY BLADEX8 ULTRA INSTR MARKER OPHTHALMIC 4.25IN 4.5MM OSHER NEUMANN CORNEAL RADIAL KERATOTOMY BLADEX8 ULTRA INSTRUMENTS
Catalog Number
60-8038
Brand Name
Symmetry Surgical
Version/Model Number
60-8038
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 9999
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
FZZ
Product Code Name
Marker, Skin
Public Device Record Key
2f1c4a50-407c-40a2-be7f-cd0bcf08f5c2
Public Version Date
May 10, 2021
Public Version Number
4
DI Record Publish Date
December 21, 2017
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 | 7981 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3309 |