Duns Number:438793622
Device Description: TL SHORT TENSIONER TIP
Catalog Number
20116735
Brand Name
TRUELOK SYSTEM
Version/Model Number
1
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
-
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
K941048
Product Code
LXT
Product Code Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Public Device Record Key
ae37e64c-4273-4478-8dd1-515403bcedde
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
April 24, 2018
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 | 64 |
2 | A medical device with a moderate to high risk that requires special controls. | 6371 |