Catalog Number

-

Brand Name

Stryker

Version/Model Number

5820-13-130

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

GFF

Product Code Name

Bur, Surgical, General & Plastic Surgery

Public Device Record Key

5ebb3360-1dd8-4ebb-a491-ecc834f1636d

Public Version Date

July 13, 2022

Public Version Number

1

DI Record Publish Date

July 05, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-