SD03503418

GUDID 10887587076706

MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH W/ 18MM STOP/50MM

SYNTHES (U.S.A.) LP

Fluted surgical drill bit, reusable
Primary Device ID10887587076706
NIH Device Record Key4e59dc19-b830-489c-8cfc-8960416edc48
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSD03.503.418
Catalog NumberSD03503418
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
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
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
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
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
GS110887587076706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDRILL, BONE, POWERED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


[10887587076706]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-22
Device Publish Date2021-07-14

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H6792042320 - NA2024-07-24 3.5MM SHAFT SCREW 32MM
H6792042340 - NA2024-07-24 3.5MM SHAFT SCREW 34MM
H6792042360 - NA2024-07-24 3.5MM SHAFT SCREW 36MM
H6792042380 - NA2024-07-24 3.5MM SHAFT SCREW 38MM

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