Catalog Number

MDSB10700STND

Brand Name

Medline

Version/Model Number

MDSB10700STND

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IYO

Product Code Name

System, imaging, pulsed echo, ultrasonic

Public Device Record Key

00894f9d-0de4-4a65-aa0d-c81cddb9c3be

Public Version Date

January 14, 2021

Public Version Number

1

DI Record Publish Date

January 06, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-