Duns Number:058614483
Device Description: Reliant Pencil,Erbe, Holster
Catalog Number
VL2600E
Brand Name
Valleylab
Version/Model Number
VL2600E
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 16, 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
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
-
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
e79e3a4a-89bf-4d45-9e6c-503e727dba09
Public Version Date
August 09, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10884524001319
Quantity per Package
50
Contains DI Package
20884524001316
Package Discontinue Date
-
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 |