Catalog Number

141-01-11

Brand Name

Novation Ceramic AHS

Version/Model Number

141-01-11

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2019

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

1037184f-b8f5-43f5-9546-5da7f9325eb2

Public Version Date

July 22, 2022

Public Version Number

4

DI Record Publish Date

November 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-