Catalog Number

-

Brand Name

MIDLINE II

Version/Model Number

M331908

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)

Yes

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

K133286

Product Code

OVD

Product Code Name

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Public Device Record Key

5c5cc780-9d3d-4095-b7f8-f1b55c7d508d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-