Valkyrie Thoracic Fixation System - Driver Bit, Short - J.M. Longyear Manufacturing, LLC

Duns Number:081307059

Device Description: Driver Bit, Short

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


More Product Details

Catalog Number

01-04-3035

Brand Name

Valkyrie Thoracic Fixation System

Version/Model Number

01-04-3035

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

Yes

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

HXX

Product Code Name

Screwdriver

Device Record Status

Public Device Record Key

7efc2147-9bcd-4e44-89be-f0e186f29132

Public Version Date

March 03, 2022

Public Version Number

2

DI Record Publish Date

April 09, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"J.M. LONGYEAR MANUFACTURING, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 34