Duns Number:049290364
Device Description: ELMED MC/MS M/M ELECTROSURGICAL UNIT, SMART-O-MATIC CIRCUIT, MONOPOLAR AND BIPOLAR, WITH M ELMED MC/MS M/M ELECTROSURGICAL UNIT, SMART-O-MATIC CIRCUIT, MONOPOLAR AND BIPOLAR, WITH MICRO AND MACRO OUTPUT, DUAL BUTTON HANDLE OR DOUBLE PEDAL FOOTSWITCH OPERATION
Catalog Number
5350
Brand Name
ELMED
Version/Model Number
5350
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
-
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
BWA
Product Code Name
Unit, Electrosurgical Andcoagulation, With Accessories
Public Device Record Key
5417bb8f-bd7c-49de-acb1-4f9443532142
Public Version Date
April 09, 2018
Public Version Number
1
DI Record Publish Date
March 07, 2018
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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4068 |