Catalog Number

-

Brand Name

Ultrasound Probe Cover Biopsy Needle Guide Kit

Version/Model Number

28-EG129

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K011265,K011265

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

b0e340c0-8f53-49d2-8a25-2af1c7ee6e32

Public Version Date

July 11, 2022

Public Version Number

1

DI Record Publish Date

July 01, 2022

Package DI Number

10848340017398

Quantity per Package

10

Contains DI Package

00848340017391

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-