Fixation Screw 1000-41

GUDID 00841307126211

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID00841307126211
NIH Device Record Key2ed94da2-5f2d-4f68-97f1-8e75f82ec5fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixation Screw
Version Model Number1000-41
Catalog Number1000-41
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
GS100841307126211 [Unit of Use]
GS110841307126218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841307126211]

Moist Heat or Steam Sterilization


[00841307126211]

Moist Heat or Steam Sterilization


[00841307126211]

Moist Heat or Steam Sterilization


[00841307126211]

Moist Heat or Steam Sterilization


[00841307126211]

Moist Heat or Steam Sterilization


[00841307126211]

Moist Heat or Steam Sterilization


[00841307126211]

Moist Heat or Steam Sterilization


[00841307126211]

Moist Heat or Steam Sterilization


[00841307126211]

Moist Heat or Steam Sterilization


[00841307126211]

Moist Heat or Steam Sterilization


[00841307126211]

Moist Heat or Steam Sterilization


[00841307126211]

Moist Heat or Steam Sterilization


[00841307126211]

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

On-Brand Devices [Fixation Screw]

008413071262281000-42
008413071262111000-41
008413071261291000-28
008413071260821000-23
008413071260751000-22
008413071260371000-19
008413071295021000-06
008413071295571000-15

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