Maestro™ Remote Control Cable -50' - Remote Control Cable - BOSTON SCIENTIFIC CORPORATION

Duns Number:021717889

Device Description: Remote Control Cable

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More Product Details

Catalog Number

M004SVGA500

Brand Name

Maestro™ Remote Control Cable -50'

Version/Model Number

M004SVGA500

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

-

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

P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P020025,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003,P980003

Product Code Details

Product Code

LPB

Product Code Name

Cardiac ablation percutaneous catheter

Device Record Status

Public Device Record Key

29ed5f21-2971-4cbe-be15-dd57d8c4e362

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BOSTON SCIENTIFIC CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 536
2 A medical device with a moderate to high risk that requires special controls. 8659
3 A medical device with high risk that requires premarket approval 1821
U Unclassified 35