ZOOM® LATITUDE® - programmer/recorder/monitor - BOSTON SCIENTIFIC CORPORATION

Duns Number:106295384

Device Description: programmer/recorder/monitor

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More Product Details

Catalog Number

-

Brand Name

ZOOM® LATITUDE®

Version/Model Number

3120

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

P910077

Product Code Details

Product Code

LWS

Product Code Name

Implantable cardioverter defibrillator (non-CRT)

Device Record Status

Public Device Record Key

f1873398-7de3-4d0e-ac8a-55869281c1fe

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 03, 2018

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