ARTISAN™ SPACE MAINTENANCE SYSTEM - RESCUE SCREW 7000056 1.4MMX3MM 6PK - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: RESCUE SCREW 7000056 1.4MMX3MM 6PK

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

ARTISAN™ SPACE MAINTENANCE SYSTEM

Version/Model Number

7000056

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 08, 2018

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K110259,K110259

Product Code Details

Product Code

DZE

Product Code Name

IMPLANT, ENDOSSEOUS, ROOT-FORM

Device Record Status

Public Device Record Key

f28a32e3-704a-4f61-ac8b-52ce3d5a4cce

Public Version Date

February 06, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2015

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