n/a - BLADE X1204149 TL DISC 4X30 - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: BLADE X1204149 TL DISC 4X30

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More Product Details

Catalog Number

-

Brand Name

n/a

Version/Model Number

X1204149

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

-

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

GAD

Product Code Name

RETRACTOR

Device Record Status

Public Device Record Key

e473c0c0-41a1-4427-85c2-50765c4d7631

Public Version Date

March 29, 2018

Public Version Number

2

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