Catalog Number

355324

Brand Name

ProMax™ Series Bard® C-Max™ Cutting Loop

Version/Model Number

355324

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

-

Product Code

FAS

Product Code Name

ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Public Device Record Key

ae074b8a-df93-4a9e-a2a1-f44541a9a8f3

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

July 23, 2016

Package DI Number

10801741018616

Quantity per Package

5

Contains DI Package

00801741018619

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA