Duns Number:067584601
Device Description: VertebraLINK Posterior Disc Prep Tray 2
Catalog Number
84-0921
Brand Name
VertebraLINK
Version/Model Number
84-0921
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
-
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
LRP
Product Code Name
Tray, Surgical
Public Device Record Key
839fb1de-c1bf-4363-a73e-09fcbd1093e7
Public Version Date
November 22, 2018
Public Version Number
2
DI Record Publish Date
July 06, 2018
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 | 242 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 337 |
| U | Unclassified | 12 |