Catalog Number

SW984K

Brand Name

ACTIV L

Version/Model Number

SW984K

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

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

MJO

Product Code Name

Prosthesis, intervertebral disc

Public Device Record Key

a4e62c1d-4b5b-47bf-8dd4-c448f182c20e

Public Version Date

April 21, 2021

Public Version Number

4

DI Record Publish Date

March 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-