Catalog Number

-

Brand Name

PRECISE OFFSET PARTIAL 0.5MM L

Version/Model Number

751-050

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

ETB

Product Code Name

Prosthesis, Partial Ossicular Replacement

Public Device Record Key

655b4a19-f2b5-4759-bc15-f54263ecf759

Public Version Date

September 07, 2020

Public Version Number

2

DI Record Publish Date

October 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-