Duns Number:130814890
Device Description: Round Loop,Loop Size: 20mm x 12mm
Catalog Number
LE-28-212
Brand Name
NA
Version/Model Number
Loop Electrode
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"
Yes
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
K022593,K022593
Product Code
HGI
Product Code Name
Electrocautery, Gynecologic (And Accessories)
Public Device Record Key
4de62756-95f4-483b-987a-a3c13345448b
Public Version Date
May 27, 2019
Public Version Number
4
DI Record Publish Date
October 10, 2016
Package DI Number
10852073002644
Quantity per Package
5
Contains DI Package
00852073002647
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |