Catalog Number

-

Brand Name

Capella2 Starter Kit

Version/Model Number

8-69-42800

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

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

K061443

Product Code

EWO

Product Code Name

Audiometer

Public Device Record Key

ddfb5ec6-9bf0-47d2-9455-490cbe40cc4f

Public Version Date

December 10, 2018

Public Version Number

1

DI Record Publish Date

November 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-