42002

GUDID H980420020

1.0MM TI MESH PLATE 38MM X 42MM/4MM X 4MM HOLES

SYNTHES (U.S.A.) LP

Craniofacial fixation plate, non-bioabsorbable
Primary Device IDH980420020
NIH Device Record Keya2de3425-0fe5-43f6-a86a-272150d0045d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number420.02
Catalog Number42002
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
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
GS110887587049007 [Primary]
HIBCCH980420020 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

Moist Heat or Steam Sterilization


[H980420020]

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

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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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