Catalog Number

92142

Brand Name

Implant inserter

Version/Model Number

92142

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

K955713

Product Code

LXB

Product Code Name

Hearing aid, bone conduction

Public Device Record Key

0966243a-5eff-4e49-8804-137cf1f447a8

Public Version Date

September 14, 2021

Public Version Number

4

DI Record Publish Date

June 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-