Catalog Number

S381572

Brand Name

NeoZoline

Version/Model Number

S381572

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

ETD

Product Code Name

Tube, Tympanostomy

Public Device Record Key

57e7e5c6-d766-4ab7-870d-151c8539a49e

Public Version Date

January 22, 2021

Public Version Number

3

DI Record Publish Date

October 15, 2015

Package DI Number

M6333815721

Quantity per Package

10

Contains DI Package

M633S3815720

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box