487966

GUDID 10887587055848

TI MULTI VECTOR DISTRACTOR ASSEMBLY/RIGHT WITH 35MM ARMS

SYNTHES (U.S.A.) LP

Implantable craniofacial bone distractor
Primary Device ID10887587055848
NIH Device Record Key529bffa4-7b5d-48a6-9677-172dbe49ffa9
Commercial Distribution StatusIn Commercial Distribution
Version Model Number487.966
Catalog Number487966
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 Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110887587055848 [Primary]
HIBCCH9804879660 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZLSCREW, FIXATION, INTRAOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10887587055848]

Moist Heat or Steam Sterilization


[10887587055848]

Moist Heat or Steam Sterilization


[10887587055848]

Moist Heat or Steam Sterilization


[10887587055848]

Moist Heat or Steam Sterilization


[10887587055848]

Moist Heat or Steam Sterilization


[10887587055848]

Moist Heat or Steam Sterilization


[10887587055848]

Moist Heat or Steam Sterilization


[10887587055848]

Moist Heat or Steam Sterilization


[10887587055848]

Moist Heat or Steam Sterilization


[10887587055848]

Moist Heat or Steam Sterilization


[10887587055848]

Moist Heat or Steam Sterilization


[10887587055848]

Moist Heat or Steam Sterilization


[10887587055848]

Moist Heat or Steam Sterilization


[10887587055848]

Moist Heat or Steam Sterilization


[10887587055848]

Moist Heat or Steam Sterilization


[10887587055848]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-23
Device Publish Date2015-09-14

Devices Manufactured by SYNTHES (U.S.A.) LP

10886982297280 - NA2024-09-11 SCHANZ PIN REMOVAL TOOL
H9814871830 - Click'X2024-09-11 7.0MM TI CLICK'X® MONOAXIAL PEDICLE SCREW 90MM THRD LENGTH
H9812982060 - NA2024-07-24 ANGLED LAMINA HOOK/ DUAL-OPENING SIDE
H6792042280 - NA2024-07-24 3.5MM SHAFT SCREW 28MM
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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