GPS® Extended Range Extra Light Retention Replacement Male (Red) 1000-92R

GUDID 00841307130324

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID00841307130324
NIH Device Record Keybda23e62-a4c7-4170-b87d-9d982a2d95df
Commercial Distribution StatusIn Commercial Distribution
Brand NameGPS® Extended Range Extra Light Retention Replacement Male (Red)
Version Model Number1000-92R
Catalog Number1000-92R
Company DUNS868856969
Company NameIMPLANT DIRECT SYBRON MANUFACTURING LLC
Device Count4
DM Exemptfalse
Pre-market Exempttrue
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
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
GS100841307130324 [Unit of Use]
GS110841307130321 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841307130324]

Moist Heat or Steam Sterilization


[00841307130324]

Moist Heat or Steam Sterilization


[00841307130324]

Moist Heat or Steam Sterilization


[00841307130324]

Moist Heat or Steam Sterilization


[00841307130324]

Moist Heat or Steam Sterilization


[00841307130324]

Moist Heat or Steam Sterilization


[00841307130324]

Moist Heat or Steam Sterilization


[00841307130324]

Moist Heat or Steam Sterilization


[00841307130324]

Moist Heat or Steam Sterilization


[00841307130324]

Moist Heat or Steam Sterilization


[00841307130324]

Moist Heat or Steam Sterilization


[00841307130324]

Moist Heat or Steam Sterilization


[00841307130324]

Moist Heat or Steam Sterilization


[00841307130324]

Moist Heat or Steam Sterilization


[00841307130324]

Moist Heat or Steam Sterilization


[00841307130324]

Moist Heat or Steam Sterilization


[00841307130324]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-20
Device Publish Date2024-03-12

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00841307129540 - Long Fixation Screw2024-03-20
00841307129557 - Fixation Screw2024-03-20
00841307129571 - Duo-Grip™ Long Fixation Screw2024-03-20
00841307129588 - Duo-Grip™ Fixation Screw2024-03-20
00841307129595 - Duo-Grip™ Fixation Screw Extra Short2024-03-20

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