Catalog Number

-

Brand Name

Prestige LP Streamlined Instruments

Version/Model Number

6975225

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

P090029

Product Code

MJO

Product Code Name

Prosthesis, intervertebral disc

Public Device Record Key

d39a9757-e061-46de-8a44-9a8d1eb59dc0

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

February 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-