Catalog Number

-

Brand Name

Trial BiPolar Head

Version/Model Number

112-24-0048

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

K133370

Product Code

HWT

Product Code Name

Template

Public Device Record Key

fe329a8e-8913-4c80-84b2-c4d982f7f055

Public Version Date

June 18, 2019

Public Version Number

3

DI Record Publish Date

October 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-