Catalog Number

932999014

Brand Name

2.7mm Ligament Washer-Spiked

Version/Model Number

932999014

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

-

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

953a660d-fff8-4a48-9c7e-1c3b3f4b0ad7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 04, 2016

Package DI Number

EMAH9329990141

Quantity per Package

1

Contains DI Package

EMAH9329990140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-