Duns Number:013469890
Device Description: MicroKeratome Blades, Laser Calibrated XP minus 10. Have the ultimate control of corneal f MicroKeratome Blades, Laser Calibrated XP minus 10. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx
Catalog Number
MK-101101-10
Brand Name
NA
Version/Model Number
MK-101101-10
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
8bdcb21e-d0da-4232-86d6-ab0586053ad0
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 13, 2019
Package DI Number
30810003221125
Quantity per Package
10
Contains DI Package
10810003221121
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 |