Duns Number:486711679
Device Description: 10.0MM TI DUAL CORE USS 40MM SIDE-OPENING SCREW F/6.0MM ROD
Catalog Number
04602140
Brand Name
USS
Version/Model Number
04.602.140
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
K003061
Product Code
KWP
Product Code Name
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Public Device Record Key
6c2af423-c82e-4c93-9153-d7619a79fc0b
Public Version Date
July 22, 2022
Public Version Number
1
DI Record Publish Date
July 14, 2022
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 | 8630 |
2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
U | Unclassified | 2 |