Catalog Number

5363

Brand Name

Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit

Version/Model Number

5363

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

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

K970893,K973958,K970893,K973958

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

d74f8e0a-0e77-4b8d-86d1-adac8973a8fd

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

May 17, 2021

Package DI Number

10841912106896

Quantity per Package

24

Contains DI Package

00841912106899

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-