Duns Number:030650113
Device Description: Original Malis™ Irrigator #80-1164 Irrigation Bipolar Set for Malis System CMC-II & CMC-II Original Malis™ Irrigator #80-1164 Irrigation Bipolar Set for Malis System CMC-II & CMC-III
Catalog Number
NU1060
Brand Name
Medovations®
Version/Model Number
NU1060
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
917ad549-ea4b-4ac1-9f29-675797619838
Public Version Date
April 23, 2019
Public Version Number
8
DI Record Publish Date
September 17, 2016
Package DI Number
M783NU10601
Quantity per Package
10
Contains DI Package
M783NU10600
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 109 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 207 |