400666

GUDID 20887587044849

1.7MM TI EMERGENCY SCREW W/FLUTED TIP 16MM

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID20887587044849
NIH Device Record Key5362aaa5-99e5-471e-91c0-c0b2020beaa7
Commercial Distribution StatusIn Commercial Distribution
Version Model Number400.666
Catalog Number400666
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count5
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
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
GS120887587044849 [Primary]
GS180887587044841 [Unit of Use]
HIBCCH9804006660 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


[20887587044849]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-14

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

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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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