Duns Number:094651270
Device Description: Electrosurgical Loop Electrode, 25mm Wide X 8mm Deep, Round Loop, 11cm Shaft Length, with Electrosurgical Loop Electrode, 25mm Wide X 8mm Deep, Round Loop, 11cm Shaft Length, with Safe-T-Gauge
Catalog Number
DLP-B11
Brand Name
UtahLoop
Version/Model Number
LETZ Electrode
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K951032,K905263,K905263,K951032,K951032,K905263
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
7daa4861-3ff5-494d-9c6c-8695f8a719ef
Public Version Date
December 18, 2019
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
H671DLPB112
Quantity per Package
10
Contains DI Package
H671DLPB111
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Overpack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 274 |