Catalog Number

CII-678M-06

Brand Name

M6-C

Version/Model Number

FA 0194-01

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

P170036

Product Code

QLQ

Product Code Name

Manual Instruments Designed For Total Disc Replacement Device

Public Device Record Key

e18d5e23-cd86-49af-85ef-f8460f8a2209

Public Version Date

October 19, 2020

Public Version Number

2

DI Record Publish Date

March 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-