Catalog Number

355301

Brand Name

ProMax™ Series Bard® C-Max™ Cutting Loop

Version/Model Number

355301

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

53e9e48d-5eaf-4135-b64d-0411994cb3c4

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

July 23, 2016

Package DI Number

10801741018517

Quantity per Package

5

Contains DI Package

00801741018510

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA