Catalog Number

93184

Brand Name

Baha

Version/Model Number

93184

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

K945154

Product Code

FZE

Product Code Name

PROSTHESIS, NOSE, INTERNAL

Public Device Record Key

b1340d7d-3cbc-4fbf-9946-e04579bbd7a9

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

July 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-