Catalog Number

-

Brand Name

PRECISE CENTERED TOTAL 2.00MM L

Version/Model Number

705-200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

d262c5c7-3939-4f1f-9088-eeb427c0e0f0

Public Version Date

July 27, 2020

Public Version Number

4

DI Record Publish Date

April 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-