Midas Rex® - TUBE TT12A LEGEND 12CM T12 TELE ANGLED - MEDTRONIC POWERED SURGICAL SOLUTIONS

Duns Number:098308849

Device Description: TUBE TT12A LEGEND 12CM T12 TELE ANGLED

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More Product Details

Catalog Number

-

Brand Name

Midas Rex®

Version/Model Number

TT12A

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

K020069

Product Code Details

Product Code

HBB

Product Code Name

MOTOR, DRILL, PNEUMATIC

Device Record Status

Public Device Record Key

58491a2f-bb1b-4a67-859b-e2192031523f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC POWERED SURGICAL SOLUTIONS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 450
2 A medical device with a moderate to high risk that requires special controls. 3534