Duns Number:154614119
Device Description: VECTOR TAS SINGLE DELTA SPRING With SWIVEL -Qty 6
Catalog Number
-
Brand Name
VECTOR TAS
Version/Model Number
601-0034
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"
-
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
OAT
Product Code Name
Implant, Endosseous, Orthodontic
Public Device Record Key
9714e077-c420-47d9-9d73-6a2d8da6e0f5
Public Version Date
October 29, 2019
Public Version Number
5
DI Record Publish Date
October 16, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 199 |