Catalog Number

NC828T

Brand Name

Excia® ML

Version/Model Number

NC828T

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 16, 2021

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

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

-

Product Code

MEH

Product Code Name

Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Public Device Record Key

7e64aaa8-d4d7-473a-973a-dfb7f20ff4f6

Public Version Date

January 19, 2022

Public Version Number

7

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-