Duns Number:081224143
Device Description: NON-RATCHETING T-HANDLE MINI AO DRIVER
Catalog Number
-
Brand Name
Spider Cervical Plating System
Version/Model Number
N60001503
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"
-
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
HXX
Product Code Name
SCREWDRIVER
Public Device Record Key
43200db9-255b-469e-9215-15d38c10ae8a
Public Version Date
June 03, 2021
Public Version Number
4
DI Record Publish Date
September 04, 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 | 1719 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3162 |
| U | Unclassified | 25 |