Duns Number:079940465
Device Description: H-TYPE SHARP TIP DISPOSABLE DERMAL ELECTRODE, STERILE
Catalog Number
H10008
Brand Name
BOVIE®
Version/Model Number
H10008
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
-
Product Code
HGI
Product Code Name
Electrocautery, Gynecologic (And Accessories)
Public Device Record Key
46d9078c-1ffc-4af6-995d-ecb588558213
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
June 15, 2017
Package DI Number
10607151012158
Quantity per Package
50
Contains DI Package
00607151012151
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 |