Duns Number:049290364
Device Description: 45 DEGREE ANGLED SHAFT WITH STRAIGHT TIP, 14” (36 CM), REUSABLE ELECTRODE FOR USE WITH HAN 45 DEGREE ANGLED SHAFT WITH STRAIGHT TIP, 14” (36 CM), REUSABLE ELECTRODE FOR USE WITH HANDLE 37-5300
Catalog Number
37-5302
Brand Name
ELMED
Version/Model Number
37-5302
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
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
83953e30-a845-412a-bae7-f978e611e358
Public Version Date
July 02, 2018
Public Version Number
1
DI Record Publish Date
May 30, 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 |