Duns Number:058614483
Device Description: Rocker Switch Pencil Reusable
Catalog Number
-
Brand Name
Valleylab
Version/Model Number
E2100E
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 06, 2020
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
-
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
K942183,K942183
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
eae0f715-1b7d-4896-b28e-a643a466ec60
Public Version Date
September 13, 2022
Public Version Number
8
DI Record Publish Date
September 24, 2016
Package DI Number
10884524001913
Quantity per Package
10
Contains DI Package
20884524001910
Package Discontinue Date
August 06, 2020
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |