Catalog Number

BT10M5S8A

Brand Name

BT10M5S8A

Version/Model Number

BT10M5S8A

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K934638

Product Code

JOP

Product Code Name

Transducer, Ultrasonic

Public Device Record Key

bad0a632-5ae1-4e81-b0f0-6476831e0ae2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-