MAST QUADRANT(TM) Retractor System - 80MM LEFT HALF TUBE - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: 80MM LEFT HALF TUBE

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More Product Details

Catalog Number

-

Brand Name

MAST QUADRANT(TM) Retractor System

Version/Model Number

X0905267

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 14, 2020

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

2cb051c6-8b9c-4aae-bb6c-309c8f946a24

Public Version Date

February 17, 2020

Public Version Number

3

DI Record Publish Date

October 30, 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