Catalog Number

NC816T

Brand Name

Excia® M

Version/Model Number

NC816T

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 13, 2022

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

e203aa45-8567-44fb-b404-f8bd4bb1c0e0

Public Version Date

July 18, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-