Duns Number:315018218
Device Description: SSE TI PIN FOR HOOK/COUNTER-HOOK 60MM
Catalog Number
SX398T
Brand Name
SSE
Version/Model Number
SX398T
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 29, 2015
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
-
Product Code
MNI
Product Code Name
ORTHOSIS, SPINAL PEDICLE FIXATION
Public Device Record Key
20f11985-02f9-4aad-9461-7bce92ef6864
Public Version Date
January 16, 2020
Public Version Number
4
DI Record Publish Date
September 24, 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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |