Catalog Number

S400-654S

Brand Name

Spectrum Designs Medical

Version/Model Number

Voloshin Dorsal Columella, size 5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

FZE

Product Code Name

Prosthesis, Nose, Internal

Public Device Record Key

87b2e946-61cb-4d1a-97b2-70c4b04ede21

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-