DIRECTguide™ Surgical Kit - Conical GSK-C

GUDID 10841307128236

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID10841307128236
NIH Device Record Keyff8fc9ff-e641-4dd3-b180-167e48038d2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIRECTguide™ Surgical Kit - Conical
Version Model NumberGSK-C
Catalog NumberGSK-C
Company DUNS868856969
Company NameIMPLANT DIRECT SYBRON MANUFACTURING LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110841307128236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10841307128236]

Moist Heat or Steam Sterilization


[10841307128236]

Moist Heat or Steam Sterilization


[10841307128236]

Moist Heat or Steam Sterilization


[10841307128236]

Moist Heat or Steam Sterilization


[10841307128236]

Moist Heat or Steam Sterilization


[10841307128236]

Moist Heat or Steam Sterilization


[10841307128236]

Moist Heat or Steam Sterilization


[10841307128236]

Moist Heat or Steam Sterilization


[10841307128236]

Moist Heat or Steam Sterilization


[10841307128236]

Moist Heat or Steam Sterilization


[10841307128236]

Moist Heat or Steam Sterilization


[10841307128236]

Moist Heat or Steam Sterilization


[10841307128236]

Moist Heat or Steam Sterilization


[10841307128236]

Moist Heat or Steam Sterilization


[10841307128236]

Moist Heat or Steam Sterilization


[10841307128236]

Moist Heat or Steam Sterilization


[10841307128236]

Moist Heat or Steam Sterilization


[10841307128236]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-21
Device Publish Date2023-11-13

Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC

10841307131014 - DIRECTguide™ Guided Surgery Kit - Empty2024-05-28
10841307131021 - DIRECTguide™ Guided Surgery Kit - Legacy2024-05-28
10841307131038 - DIRECTguide™ Guided Surgery Kit - Conical2024-05-28
10841307131045 - DIRECTguide™ Guided Step Drill 2024-05-28
10841307131052 - DIRECTguide™ Guided Step Drill 2024-05-28
10841307131069 - DIRECTguide™ Guided Step Drill 2024-05-28
10841307131076 - DIRECTguide™ Guided Step Drill 2024-05-28
10841307131083 - DIRECTguide™ Guided Step Drill 2024-05-28

Trademark Results [DIRECTguide]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIRECTGUIDE
DIRECTGUIDE
97918054 not registered Live/Pending
Implant Direct Sybron International LLC
2023-05-03
DIRECTGUIDE
DIRECTGUIDE
74699809 2095674 Dead/Cancelled
VOGEL SATELLITE TV PUBLISHING INC.
1995-07-11

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