N/A - INSTRUMENT 7351171 HOOK TRIAL EXTND BODY - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: INSTRUMENT 7351171 HOOK TRIAL EXTND BODY

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

7351171

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 17, 2021

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)

-

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

HWT

Product Code Name

TEMPLATE

Device Record Status

Public Device Record Key

31051586-64f5-4a03-9831-0123d0d5e1c2

Public Version Date

July 07, 2022

Public Version Number

4

DI Record Publish Date

December 17, 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