Duns Number:001406024
Device Description: Malosa Core LASIK Pack 2 (20/SP)
Catalog Number
MMK100/2
Brand Name
Beaver-Visitec
Version/Model Number
MMK100/2
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
-
Product Code
PZG
Product Code Name
Surgical Eye Tray
Public Device Record Key
941438ee-7219-44be-af7a-266f4708301f
Public Version Date
November 23, 2021
Public Version Number
1
DI Record Publish Date
November 15, 2021
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 | 441 |
2 | A medical device with a moderate to high risk that requires special controls. | 35 |
U | Unclassified | 34 |