MatrixMANDIBLE SD317879

GUDID H980SD3178790

MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH/50MM

Synthes GmbH

Fluted surgical drill bit, reusable
Primary Device IDH980SD3178790
NIH Device Record Key9bf3bf6b-c750-44c2-9177-739bacfa0fd2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMatrixMANDIBLE
Version Model NumberSD317.879
Catalog NumberSD317879
Company DUNS486711679
Company NameSynthes GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110887587002538 [Primary]
HIBCCH980SD3178790 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDRILL, BONE, POWERED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H980SD3178790]

Moist Heat or Steam Sterilization


[H980SD3178790]

Moist Heat or Steam Sterilization


[H980SD3178790]

Moist Heat or Steam Sterilization


[H980SD3178790]

Moist Heat or Steam Sterilization


[H980SD3178790]

Moist Heat or Steam Sterilization


[H980SD3178790]

Moist Heat or Steam Sterilization


[H980SD3178790]

Moist Heat or Steam Sterilization


[H980SD3178790]

Moist Heat or Steam Sterilization


[H980SD3178790]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-25
Device Publish Date2022-07-15

On-Brand Devices [MatrixMANDIBLE]

H980035031850MATRIXMANDIBLE BENDNG TEMPLATE F/1.25MM 2X2H TENSION BAND PL
H980035031750MATRIXMANDIBLE BENDNG TEMPLATE F/2.0MM BROAD 3X3 ANGLE PLATE
H980035031730MATRIXMANDIBLE BENDNG TEMPLATE F/2.0MM BROAD CRESCENT PLATES
H980035031710MATRIXMANDIBLE BENDNG TEMPLATE F/1.5MM 6H CRESCENT PLATES
H980035031700MATRIXMANDIBLE BENDNG TEMPLATE F/1.5MM THICK 3X3 ANGLE PLATE
H980035031690MATRIXMANDIBLE BENDNG TEMPLATE F/1.5MM THK 3X3 STRAIGHT PLAT
H980035031660MATRIXMANDIBLE BENDNG TEMPLATE F/1.25MM THICK ANGLE PLATES
H980035031650MATRIXMANDIBLE BENDNG TEMPLATE F/1.25MM 3X3 CRESCENT PLATES
H980035031640MATRIXMANDIBLE BENDNG TEMPLATE F/1.25MM 2X2 CRESCENT PLATES
H980035031610MATRIXMANDIBLE BENDNG TEMPLATE F/1.0MM BROAD TENSION BAND PL
H980035030700MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-SHORT
H980035030690MATRIXMANDIBLE HOLDING SLEEVE LONG FOR USE WITH 03.503.068
10887587034607GRAPHIC CASE MEDIUM FOR MATRIXMANDIBLE SYSTEM
H980SD3178790MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH/50MM

Trademark Results [MatrixMANDIBLE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MATRIXMANDIBLE
MATRIXMANDIBLE
87315665 5399668 Live/Registered
DePuy Synthes, Inc.
2017-01-27

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