N/A - INSTRUMENT 8120000 7MM CLOSED CONN TRIAL - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: INSTRUMENT 8120000 7MM CLOSED CONN TRIAL

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

8120000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 08, 2018

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

7b489aa7-3631-4dec-9889-e685afbf0d76

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

December 16, 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