0450003401

GUDID H98004500034010

TI OBA EMERGENCY SCREW 4MM

SYNTHES (U.S.A.) LP

Orthodontic anchoring screw
Primary Device IDH98004500034010
NIH Device Record Key849c6538-bd10-4dfe-ba74-ba2dd21dceca
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.500.034.01
Catalog Number0450003401
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
GS110887587016641 [Primary]
HIBCCH98004500034010 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OATImplant, endosseous, orthodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H98004500034010]

Moist Heat or Steam Sterilization


[H98004500034010]

Moist Heat or Steam Sterilization


[H98004500034010]

Moist Heat or Steam Sterilization


[H98004500034010]

Moist Heat or Steam Sterilization


[H98004500034010]

Moist Heat or Steam Sterilization


[H98004500034010]

Moist Heat or Steam Sterilization


[H98004500034010]

Moist Heat or Steam Sterilization


[H98004500034010]

Moist Heat or Steam Sterilization


[H98004500034010]

Moist Heat or Steam Sterilization


[H98004500034010]

Moist Heat or Steam Sterilization


[H98004500034010]

Moist Heat or Steam Sterilization


[H98004500034010]

Moist Heat or Steam Sterilization


[H98004500034010]

Moist Heat or Steam Sterilization


[H98004500034010]

Moist Heat or Steam Sterilization


[H98004500034010]

Moist Heat or Steam Sterilization


[H98004500034010]

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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H6792042380 - NA2024-07-24 3.5MM SHAFT SCREW 38MM

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