Catalog Number

P001000-04

Brand Name

Biim Ultrasound L12-4 Linear Array Transducer (Version P2.0)

Version/Model Number

P001000-04

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

K173138,K173138,K173138,K173138,K173138

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

a24299c8-b071-42b0-8248-8dd1fc7e0172

Public Version Date

October 29, 2019

Public Version Number

1

DI Record Publish Date

October 21, 2019

Package DI Number

07090045490402

Quantity per Package

1

Contains DI Package

07090045490365

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX