04305142

GUDID H980043051420

2.5MM/4.0MM TI SCHANZ SCREW F/ SYMPHYSIS W/22MM THREAD LENGT

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDH980043051420
NIH Device Record Key2a1ba4cd-b4d7-45b1-82d3-9a5531930fa5
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.305.142
Catalog Number04305142
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
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
GS110887587015248 [Primary]
HIBCCH980043051420 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

Moist Heat or Steam Sterilization


[H980043051420]

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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