Standard Surgical Kit CSSK

GUDID 10841307125846

Drills & Tools (Qty 23) Tray & Pan (Qty1)

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 ID: 10841307125846
• NIH Device Record Key: 74268e41-2c43-4c2b-a42f-f5bc6196d7df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Surgical Kit
• Version Model Number: CSSK
• Catalog Number: CSSK
• Company DUNS: 868856969
• Company Name: IMPLANT DIRECT SYBRON MANUFACTURING LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841307125846 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202524

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

[10841307125846]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-20
• Device Publish Date: 2021-04-12

Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC

• 10841307131014 - DIRECTguide™ Guided Surgery Kit - Empty: 2024-05-28
• 10841307131021 - DIRECTguide™ Guided Surgery Kit - Legacy: 2024-05-28
• 10841307131038 - DIRECTguide™ Guided Surgery Kit - Conical: 2024-05-28
• 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