Catalog Number

-

Brand Name

Ultrasound Probe Cover Biopsy Needle Guide Kit

Version/Model Number

28-TPG115

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

da49a17e-3a9a-4c41-a2a2-b3f31eab07b9

Public Version Date

June 29, 2022

Public Version Number

1

DI Record Publish Date

June 21, 2022

Package DI Number

10848340017602

Quantity per Package

10

Contains DI Package

00848340017605

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-