Spreader Arm - Crank Side - The device is intended to be used for sternal - Coroneo Inc

Duns Number:255276362

Device Description: The device is intended to be used for sternal retraction on adult patients.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

1010807

Brand Name

Spreader Arm - Crank Side

Version/Model Number

1010807

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

GAD

Product Code Name

Retractor

Device Record Status

Public Device Record Key

902fa59a-2049-4675-9361-b5440ffac1eb

Public Version Date

October 07, 2022

Public Version Number

1

DI Record Publish Date

September 29, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CORONEO INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9