Standard Surgical Kit Mini CSSKM

GUDID 10841307125822

Drills & Tools (Qty 13) Tray & Pan (Qty 1)

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable
Primary Device ID10841307125822
NIH Device Record Key36e88817-807b-4437-b019-28dc0ef084ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameStandard Surgical Kit Mini
Version Model NumberCSSKM
Catalog NumberCSSKM
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

Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com
Phone18886496425
Emailcustomerservice@implantdirect.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110841307125822 [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

[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


[10841307125822]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-09
Device Publish Date2021-03-01

Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC

00841307129519 - Long Fixation Screw2024-03-20
00841307129526 - Dual-Grip™ Long Fixation Screw2024-03-20
00841307129533 - Dual-Grip™ Long Fixation Screw2024-03-20
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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