Catalog Number

95-6204

Brand Name

Anterior Disc Prep

Version/Model Number

95-6204

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 14, 2020

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

-

Product Code

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Public Device Record Key

5f9cef32-3751-4956-acec-77d85b38028b

Public Version Date

August 14, 2020

Public Version Number

2

DI Record Publish Date

March 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-