Catalog Number

P001137

Brand Name

Probe holder, (V2) Biim Ultrasound

Version/Model Number

P001137

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

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

b6d3440c-902f-45d0-b087-a4a1619bf544

Public Version Date

January 17, 2019

Public Version Number

6

DI Record Publish Date

January 26, 2018

Package DI Number

07090045490105

Quantity per Package

1

Contains DI Package

07090045490051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

EA