Duns Number:342243334
Device Description: TI rod 6x60mm
Catalog Number
SCC02-0060
Brand Name
TI rod 6x60mm
Version/Model Number
SCC02-0060
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"
Yes
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
NKB
Product Code Name
Orthosis, spinal pedicle fixation, for degenerative disc disease
Public Device Record Key
5b75e886-e173-480c-8b37-9fcb3127d68f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 04, 2016
Package DI Number
EMAHSCC0200601
Quantity per Package
1
Contains DI Package
EMAHSCC0200600
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 19 |
2 | A medical device with a moderate to high risk that requires special controls. | 1976 |