N/A - TAMPONADE X1116099 CANNULATED-5.0 X 35 - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: TAMPONADE X1116099 CANNULATED-5.0 X 35

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

X1116099

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)

Yes

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

98b9a368-b035-4c21-91b8-109b0056151b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 09, 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