Evera™ XT VR - ICD-VR DVBB1D1 EVERA XT US DF1 - MEDTRONIC, INC.

Duns Number:006261481

Device Description: ICD-VR DVBB1D1 EVERA XT US DF1

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More Product Details

Catalog Number

-

Brand Name

Evera™ XT VR

Version/Model Number

DVBB1D1

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

LWS

Product Code Name

Implantable cardioverter defibrillator (non-CRT)

Device Record Status

Public Device Record Key

5a8ba6b7-e223-47df-aad0-fd7969173ad6

Public Version Date

June 24, 2021

Public Version Number

7

DI Record Publish Date

May 22, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 102
2 A medical device with a moderate to high risk that requires special controls. 20495
3 A medical device with high risk that requires premarket approval 3601