Speed Torque - Barcode for Single Sterile Packaged Shipping Box - Vascugenix, LLC

Duns Number:117166275

Device Description: Barcode for Single Sterile Packaged Shipping Box

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More Product Details

Catalog Number

-

Brand Name

Speed Torque

Version/Model Number

VXST001

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)

-

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

PTL

Product Code Name

Wire, Guide, Catheter, Exempt

Device Record Status

Public Device Record Key

febc732a-bfc5-4c0d-8feb-079d92fbf6b5

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

February 03, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VASCUGENIX, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4