Duns Number:049290364
Device Description: ELMED ESU 400 DIGITAL WITH SMART-O-MATIC CIRCUIT, MONOPOLAR AND BIPOLAR, WITH RETURN ELECT ELMED ESU 400 DIGITAL WITH SMART-O-MATIC CIRCUIT, MONOPOLAR AND BIPOLAR, WITH RETURN ELECTRODE MONITOR (REM), COMPATIBLE WITH DUAL-CONTACT PATIENT PLATES
Catalog Number
5759
Brand Name
ELMED
Version/Model Number
5759
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
094a24e8-6f9f-4c4a-a985-fb7ae717f097
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 29, 2016
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 |