Catalog Number

-

Brand Name

WILDCAT PRO ALTO TOTAL

Version/Model Number

613

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 07, 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

K061853

Product Code

ETA

Product Code Name

REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Public Device Record Key

7df23b88-2898-4036-ac78-611dfb49103a

Public Version Date

January 19, 2021

Public Version Number

2

DI Record Publish Date

January 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-