Catalog Number

FW966R

Brand Name

activL®

Version/Model Number

FW966R

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

-

Product Code

QLQ

Product Code Name

Manual instruments designed for use with total disc replacement devices

Public Device Record Key

d3e824bc-26d7-413a-9c77-b7edc8ce2fe4

Public Version Date

October 04, 2021

Public Version Number

5

DI Record Publish Date

October 18, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-