Catalog Number

X31-400061

Brand Name

Extended Stroke

Version/Model Number

X31-400061

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

-

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

-

FDA Premarket Submission

-

Product Code

FZY

Product Code Name

HAMMER, SURGICAL

Public Device Record Key

391fbc45-9558-469d-899a-b7a74e5595f6

Public Version Date

May 16, 2022

Public Version Number

1

DI Record Publish Date

May 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-