N'Vision® - CABLE 8580 DATA IR FOR 8840 WIN8 GLOBAL - MEDTRONIC, INC.

Duns Number:796986144

Device Description: CABLE 8580 DATA IR FOR 8840 WIN8 GLOBAL

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More Product Details

Catalog Number

-

Brand Name

N'Vision®

Version/Model Number

8580

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

-

Product Code Details

Product Code

OUG

Product Code Name

Medical device data system

Device Record Status

Public Device Record Key

9579ad38-d058-4e63-acbf-6d34a189ea45

Public Version Date

October 07, 2019

Public Version Number

3

DI Record Publish Date

November 18, 2015

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