Duns Number:079940465
Device Description: DISPOSABLE SPLIT ADULT RETURN ELECTRODE WITH CABLE
Catalog Number
ESREC
Brand Name
Bovie
Version/Model Number
ESREC
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
K092761,K092761
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
6ffa446b-76b9-4d22-96c4-492eb7b8764c
Public Version Date
June 05, 2020
Public Version Number
4
DI Record Publish Date
August 31, 2016
Package DI Number
10607151563537
Quantity per Package
50
Contains DI Package
00607151563530
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 433 |