Catalog Number

-

Brand Name

Prodisc C

Version/Model Number

09.820.067S

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

P070001,P070001

Product Code

MJO

Product Code Name

Prosthesis, Intervertebral Disc

Public Device Record Key

4f9633cb-3691-474e-a1a5-661278cbaae3

Public Version Date

April 21, 2021

Public Version Number

4

DI Record Publish Date

October 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-