Catalog Number

5017

Brand Name

Sterile Disposable Needle Guide Kit

Version/Model Number

5017

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)

Yes

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

K970891,K970893,K971115,K971722,K970891,K970893,K971115,K971722

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

7716b565-f628-4fe4-b8f9-6775d1e2b748

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

June 14, 2019

Package DI Number

10841912106117

Quantity per Package

24

Contains DI Package

00841912106110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-