Catalog Number

P001000

Brand Name

Biim Ultrasound L12-4 Linear Array Transducer

Version/Model Number

P001000

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

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

f765f6da-d8fe-49ac-b65a-f967d0b58b4b

Public Version Date

January 17, 2019

Public Version Number

6

DI Record Publish Date

January 26, 2018

Package DI Number

07090045490082

Quantity per Package

1

Contains DI Package

07090045490006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX