NA - ROTARY MIXER - Synthes GmbH

Duns Number:486711679

Device Description: ROTARY MIXER

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More Product Details

Catalog Number

MXRUS2000

Brand Name

NA

Version/Model Number

MXR-US-2000

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

K011897,K011897

Product Code Details

Product Code

MQV

Product Code Name

FILLER, BONE VOID, CALCIUM COMPOUND

Device Record Status

Public Device Record Key

eeaa029c-4c66-43c6-99cd-c71367aa152a

Public Version Date

April 28, 2022

Public Version Number

4

DI Record Publish Date

September 14, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNTHES GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8630
2 A medical device with a moderate to high risk that requires special controls. 16671
U Unclassified 2