Catalog Number

202-82038-S

Brand Name

BladeX Blade Sterile

Version/Model Number

202-82038-S

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

-

Product Code

OUR

Product Code Name

Sacroiliac Joint Fixation

Public Device Record Key

1e22b9d0-7b82-4057-bb3c-eb31c320ab1d

Public Version Date

August 25, 2022

Public Version Number

1

DI Record Publish Date

August 17, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-