Duns Number:624083866
Device Description: Crosslink for Ø5.5mm rods, XXS, 35-43mm
Catalog Number
-
Brand Name
Momentum
Version/Model Number
UU051-70-5501
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
K191932
Product Code
NKB
Product Code Name
Thoracolumbosacral Pedicle Screw System
Public Device Record Key
19282a1f-a48b-4708-8b65-3984729ee79c
Public Version Date
February 09, 2021
Public Version Number
1
DI Record Publish Date
February 01, 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. | 716 |