Catalog Number

-

Brand Name

Huang Inner Ear Shunt

Version/Model Number

GS-2000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

Yes

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

K897049

Product Code

ESZ

Product Code Name

Tube, Shunt, Endolymphatic

Public Device Record Key

6f688e5b-05a6-4f53-a772-07f638e1ed91

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-