Duns Number:557795909
Device Description: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 5.0 x 40 mm
Catalog Number
FT.LN2.5040
Brand Name
FaSet
Version/Model Number
A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K180729
Product Code
MRW
Product Code Name
SYSTEM, FACET SCREW SPINAL DEVICE
Public Device Record Key
ee5c8456-6c79-4477-b768-48dd53058c4a
Public Version Date
March 26, 2021
Public Version Number
1
DI Record Publish Date
March 18, 2021
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. | 7203 |
U | Unclassified | 227 |