Catalog Number

007-969

Brand Name

Pro-Tec PET, 5cc HSW

Version/Model Number

007-969

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

IWR

Product Code Name

Holder, Syringe, Lead

Public Device Record Key

e6294bc4-424e-4a75-b6e2-b6eca5e90130

Public Version Date

July 19, 2022

Public Version Number

1

DI Record Publish Date

July 11, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-