Mariner Cap - Mariner Cap SP Anti-torque wrench - SEASPINE ORTHOPEDICS CORPORATION

Duns Number:079840876

Device Description: Mariner Cap SP Anti-torque wrench

Want to know more about this Product? Request more information now!


More Product Details

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

Product Characteristics

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 Details

Product Code

OWI

Product Code Name

Bone fixation cerclage, sublaminar

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SEASPINE ORTHOPEDICS CORPORATION" Characteristics
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