Fixation Screw Extra Short 1000-19S

GUDID 00841307126044

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID00841307126044
NIH Device Record Key022984ff-ecd5-4e5f-a389-46500a94d63a
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixation Screw Extra Short
Version Model Number1000-19S
Catalog Number1000-19S
Company DUNS868856969
Company NameIMPLANT DIRECT SYBRON MANUFACTURING LLC
Device Count2
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

Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841307126044 [Unit of Use]
GS110841307126041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841307126044]

Moist Heat or Steam Sterilization


[00841307126044]

Moist Heat or Steam Sterilization


[00841307126044]

Moist Heat or Steam Sterilization


[00841307126044]

Moist Heat or Steam Sterilization


[00841307126044]

Moist Heat or Steam Sterilization


[00841307126044]

Moist Heat or Steam Sterilization


[00841307126044]

Moist Heat or Steam Sterilization


[00841307126044]

Moist Heat or Steam Sterilization


[00841307126044]

Moist Heat or Steam Sterilization


[00841307126044]

Moist Heat or Steam Sterilization


[00841307126044]

Moist Heat or Steam Sterilization


[00841307126044]

Moist Heat or Steam Sterilization


[00841307126044]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-20
Device Publish Date2021-04-12

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