421521

GUDID H9804215210

TI LOW PROFILE NEURO BOX PLATE 10MM X 16MM/4 HOLES

SYNTHES (U.S.A.) LP

Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized
Primary Device IDH9804215210
NIH Device Record Key5e279efe-eb33-4069-8fb8-82f1e847c00c
Commercial Distribution StatusIn Commercial Distribution
Version Model Number421.521
Catalog Number421521
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
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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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
GS110887587050546 [Primary]
HIBCCH9804215210 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPLATE, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

Moist Heat or Steam Sterilization

[H9804215210]

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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