Catalog Number

BP105C

Brand Name

BiPad Hand Activated Disposable Bipolar Electrocautery Cord

Version/Model Number

BP105-C

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

Yes

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

K201833,K201833,K201833,K201833

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

5c70135c-91c1-47c4-96e8-0077aa6afc9f

Public Version Date

October 27, 2020

Public Version Number

1

DI Record Publish Date

October 19, 2020

Package DI Number

10860001107033

Quantity per Package

1

Contains DI Package

00860001107012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvek