Duns Number:079840876
Device Description: Mariner Cap SP Anti-torque wrench
Catalog Number
569063
Brand Name
Mariner Cap
Version/Model Number
569063
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
K201240
Product Code
OWI
Product Code Name
Bone fixation cerclage, sublaminar
Public Device Record Key
cd944459-9614-45bd-b652-536c891586ea
Public Version Date
December 02, 2020
Public Version Number
1
DI Record Publish Date
November 24, 2020
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 | 5602 |
2 | A medical device with a moderate to high risk that requires special controls. | 14020 |
U | Unclassified | 21 |