NA - CABLE 8253080 MINI SCREEN - MEDTRONIC XOMED, INC.

Duns Number:835465063

Device Description: CABLE 8253080 MINI SCREEN

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

8253080

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

K083124

Product Code Details

Product Code

ETN

Product Code Name

STIMULATOR, NERVE

Device Record Status

Public Device Record Key

f3a2a128-1ca6-4b6a-8311-1f4571087b00

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 31, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC XOMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 665
2 A medical device with a moderate to high risk that requires special controls. 1575
3 A medical device with high risk that requires premarket approval 6
U Unclassified 10