Catalog Number

5100-050-028

Brand Name

Stryker

Version/Model Number

5100050028

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

EIA

Product Code Name

UNIT, OPERATIVE DENTAL

Public Device Record Key

84b65860-6386-428d-b5b3-83c23d67d7e6

Public Version Date

March 05, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-