Duns Number:015903922
Device Description: Single Use Monopolar Suction Coagulator 10 French with 10 ft (3m) Monopolar Cord
Catalog Number
-
Brand Name
MytaMed
Version/Model Number
40-6000
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
K895337,K895337,K895337
Product Code
HAM
Product Code Name
Apparatus, Electrosurgical
Public Device Record Key
88505271-7dbe-4258-a4e0-4105d68ade37
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
July 10, 2016
Package DI Number
20841019110236
Quantity per Package
50
Contains DI Package
00841019110232
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 861 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |