Duns Number:801895244
Device Description: LEEP Ball Electrode; 3mm Diameter and 12cm Shaft
Catalog Number
-
Brand Name
LEEP Ball Electrode
Version/Model Number
B0312
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
K905747,K905747
Product Code
HGI
Product Code Name
Electrocautery, Gynecologic (And Accessories)
Public Device Record Key
404d6064-dce8-488b-8459-5b8991227854
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
August 15, 2016
Package DI Number
20888937010903
Quantity per Package
5
Contains DI Package
00888937010909
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |