Catalog Number

03650000

Brand Name

NA

Version/Model Number

03.650.000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 13, 2018

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

-

Product Code

HWA

Product Code Name

IMPACTOR

Public Device Record Key

e99bc4f9-7caa-4c72-9985-82386ca59c69

Public Version Date

October 05, 2018

Public Version Number

2

DI Record Publish Date

August 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-