Balloon Kyphoplasty Essentials Kit - KIT NH103PB-CDS 10/3 SPINE ESSEN FF CDS - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: KIT NH103PB-CDS 10/3 SPINE ESSEN FF CDS

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More Product Details

Catalog Number

-

Brand Name

Balloon Kyphoplasty Essentials Kit

Version/Model Number

NH103PB-CDS

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

K041454

Product Code Details

Product Code

HRX

Product Code Name

ARTHROSCOPE

Device Record Status

Public Device Record Key

807cc070-05ae-48b1-8a93-b1ac3de4f673

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 25, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC SOFAMOR DANEK, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13352
2 A medical device with a moderate to high risk that requires special controls. 26085
3 A medical device with high risk that requires premarket approval 190
U Unclassified 75