Catalog Number

2500-200BL

Brand Name

ANKENEY STERNAL RETRACTOR BLADE

Version/Model Number

2500-200BL

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"

Yes

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

FFO

Product Code Name

RETRACTOR, SELF-RETAINING

Public Device Record Key

59ffb6dd-dc16-4d5b-b8af-3c60c4a2e5d6

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

March 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-