Duns Number:094651270
Device Description: Electrode Sampler #1, Disposable Electrosurgical Loop and Ball Electrodes, Includes 1 ea. Electrode Sampler #1, Disposable Electrosurgical Loop and Ball Electrodes, Includes 1 ea. DLP-S11, 2 ea. DLP-M11, 1 ea. DLP-W11, 1 ea. DBL-311, & 1 ea. DBL-511
Catalog Number
DLS-100
Brand Name
LETZ
Version/Model Number
Electrode Sampler #1
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
K905263,K951032,K905263,K951032
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
7557c1a3-e2a7-4cfe-8b60-4ee5dce2f3cc
Public Version Date
December 18, 2019
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
H671DLS1001
Quantity per Package
10
Contains DI Package
H671DLS1000
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 |