Catalog Number

-

Brand Name

InflateFX® Gen II Fracture Management

Version/Model Number

IFXG2A

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

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

K041454

Product Code

HRX

Product Code Name

ARTHROSCOPE

Public Device Record Key

b36a588a-c87b-42e3-b5a6-9e8254bbdba8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-