Catalog Number

-

Brand Name

BlastX™

Version/Model Number

MC-WG-0003-12

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K163188,K163188

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

833b62bf-c66e-4b36-b368-3cd2320116f9

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

August 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-