MECTRON - MP3-a30 is a surgical insert for osteoplasty - MECTRON SPA

Duns Number:436664734

Device Description: MP3-a30 is a surgical insert for osteoplasty procedures to be used in conjunction with Mec MP3-a30 is a surgical insert for osteoplasty procedures to be used in conjunction with Mectron Piezosurgery ultrasonic handpieces.

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More Product Details

Catalog Number

03610003

Brand Name

MECTRON

Version/Model Number

MP3-a30

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

K153743

Product Code Details

Product Code

DZI

Product Code Name

Drill, Bone, Powered

Device Record Status

Public Device Record Key

8bc017c6-153a-4f36-9ab7-8d52e6fbf671

Public Version Date

July 24, 2018

Public Version Number

4

DI Record Publish Date

September 05, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MECTRON SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 45
2 A medical device with a moderate to high risk that requires special controls. 199