ProMax™ Series Bard® C-Max™ Cutting Loop - ProMax™ Series Bard® C-Max™ Cutting Loop, - C. R. Bard, Inc.

Duns Number:016898496

Device Description: ProMax™ Series Bard® C-Max™ Cutting Loop, Resectoscope Compatibility: Storz Double Stem 27 ProMax™ Series Bard® C-Max™ Cutting Loop, Resectoscope Compatibility: Storz Double Stem 27 Fr.

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More Product Details

Catalog Number

355314

Brand Name

ProMax™ Series Bard® C-Max™ Cutting Loop

Version/Model Number

355314

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FAS

Product Code Name

ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Device Record Status

Public Device Record Key

6fc35b9c-a652-4210-ae10-a8c614e47e6c

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

July 23, 2016

Additional Identifiers

Package DI Number

10801741018579

Quantity per Package

5

Contains DI Package

00801741018572

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA

"C. R. BARD, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 472
2 A medical device with a moderate to high risk that requires special controls. 1994
U Unclassified 10