Extra Long Fixation Screw (2 pieces) 1000-10XL

GUDID 10841307108672

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID10841307108672
NIH Device Record Key678f56d9-428b-43d0-bc1f-8d07ca25a6e3
Commercial Distribution Discontinuation2019-05-22
Commercial Distribution StatusNot in Commercial Distribution
Brand NameExtra Long Fixation Screw (2 pieces)
Version Model Number1000-10XL
Catalog Number1000-10XL
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841307108675 [Unit of Use]
GS110841307108672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10841307108672]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-08
Device Publish Date2015-09-14

On-Brand Devices [Extra Long Fixation Screw (2 pieces)]

108413071087331000-14XL
108413071086721000-10XL

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