Duns Number:033014361
Device Description: Capture Facet Screw
Catalog Number
510-5335
Brand Name
Capture Facet Screw System
Version/Model Number
10-10-45-3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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
MRW
Product Code Name
SYSTEM, FACET SCREW SPINAL DEVICE
Public Device Record Key
ea6c0d2c-38d0-4867-80c6-bf244b004a22
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 08, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1132 |
U | Unclassified | 13 |