Catalog Number

-

Brand Name

CORB®

Version/Model Number

3240-33

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 19, 2017

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

K811005

Product Code

HSZ

Product Code Name

INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Public Device Record Key

c919bbf1-75c2-436b-8d11-1b13580698a6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-