NA - CABLE 5433VL VENTRICAL PATIENT 12FT - MEDTRONIC, INC.

Duns Number:006261481

Device Description: CABLE 5433VL VENTRICAL PATIENT 12FT

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

5433VL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 21, 2018

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

P820003

Product Code Details

Product Code

LWP

Product Code Name

Implantable pulse generator, pacemaker (non-CRT)

Device Record Status

Public Device Record Key

679bb811-b88e-4515-a735-37974f77647a

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 23, 2014

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