Catalog Number

PDLLPT14S

Brand Name

ProDisc

Version/Model Number

PDL-L-PT14S

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

P050010

Product Code

MJO

Product Code Name

PROSTHESIS, INTERVERTEBRAL DISC

Public Device Record Key

de4655f3-4525-41a4-af19-5b6a0589088e

Public Version Date

April 21, 2021

Public Version Number

5

DI Record Publish Date

February 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-