Catalog Number

FW981R

Brand Name

activL®

Version/Model Number

FW981R

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

3ac38ee6-6b0e-48f5-9ba1-1e190c49ea1f

Public Version Date

October 04, 2021

Public Version Number

5

DI Record Publish Date

May 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-