Catalog Number

674-049

Brand Name

Needle Guide Bracket

Version/Model Number

674-049

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K093713,K093713

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

7fad721e-bcaa-4c68-96c7-33e6d3032a9d

Public Version Date

June 10, 2022

Public Version Number

10

DI Record Publish Date

August 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-