RePlant Surgical Tray RST

GUDID 10841307117506

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Instrument tray
Primary Device ID10841307117506
NIH Device Record Key56ac7990-7d4a-47dd-b807-9a9af84a2158
Commercial Distribution StatusIn Commercial Distribution
Brand NameRePlant Surgical Tray
Version Model NumberRST
Catalog NumberRST
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 Kitfalse
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
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
GS110841307117506 [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

[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


[10841307117506]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-10-21
Device Publish Date2015-09-23

Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC

10841307111627 - Legacy™ Plastic Engaging Temporary Abutment2024-12-23
10841307111634 - Legacy™ Plastic Engaging Temporary Abutment2024-12-23
10841307111641 - Legacy™ Plastic Engaging Temporary Abutment2024-12-23
10841307111696 - Legacy™ Plastic Temporary Abutment2024-12-23
10841307103585 - ReActive® Implant2024-12-20 Ø3.7 x 8 Platform 3.5mmD
10841307103592 - ReActive® Implant2024-12-20 Ø3.7 x 8 Platform 3.5mmD
10841307103608 - ReActive® Implant2024-12-20 Ø3.7 x 8 Platform 3.5mmD
10841307103615 - ReActive® Implant2024-12-20 Ø3.7 x 8 Platform 3.5mmD

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.