Catalog Number

800-716

Brand Name

Dura Separator, Baker, Reusable

Version/Model Number

800-716

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HAO

Product Code Name

Instrument, Surgical, Non-Powered

Public Device Record Key

092ddcdb-37f2-4e25-8ad5-e8674b86aea9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-