Duns Number:013469890
Device Description: MicroKeratome Blades, BD K-3000, K-4000 Compatible. Each blade is laser inspected and cal MicroKeratome Blades, BD K-3000, K-4000 Compatible. Each blade is laser inspected and calibrated. 10/bx
Catalog Number
MK-300300
Brand Name
NA
Version/Model Number
MK-300300
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
Yes
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
K020482,K020482
Product Code
HNO
Product Code Name
Keratome, Ac-Powered
Public Device Record Key
e816c0dd-8b42-4e53-90a0-8ce33e932952
Public Version Date
February 04, 2019
Public Version Number
1
DI Record Publish Date
January 03, 2019
Package DI Number
30810003221521
Quantity per Package
10
Contains DI Package
10810003221527
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 5 |