Duns Number:383228632
Device Description: UNiD Ti Dual Diameter Rod Ø 5.5 mm/Ø 6.0 mm - 16
Catalog Number
B33145600-16
Brand Name
UNID ROD
Version/Model Number
B33145600-16
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 18, 2021
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
K140738
Product Code
MNI
Product Code Name
Orthosis, Spinal Pedicle Fixation
Public Device Record Key
e525588a-df62-4c7c-94ea-e2467e20da7b
Public Version Date
May 23, 2022
Public Version Number
3
DI Record Publish Date
November 07, 2019
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 | 1328 |
2 | A medical device with a moderate to high risk that requires special controls. | 3995 |