GUIDED SURGERY KIT EPIKUT KCSEG 01

GUDID 07899995274670

GUIDED SURGERY KIT EPIKUT

Sin Sistema de Implante Nacional S/A

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

• Primary Device ID: 07899995274670
• NIH Device Record Key: 17cabb00-1346-42f6-a943-2b20149ee0c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GUIDED SURGERY KIT EPIKUT
• Version Model Number: KCSEG 01
• Catalog Number: KCSEG 01
• Company DUNS: 904569092
• Company Name: Sin Sistema de Implante Nacional S/A
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07899995274670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212404

FDA Product Code

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

Sterilization

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

[07899995274670]

Moist Heat or Steam Sterilization

[07899995274670]

Moist Heat or Steam Sterilization

[07899995274670]

Moist Heat or Steam Sterilization

[07899995274670]

Moist Heat or Steam Sterilization

[07899995274670]

Moist Heat or Steam Sterilization

[07899995274670]

Moist Heat or Steam Sterilization

[07899995274670]

Moist Heat or Steam Sterilization

[07899995274670]

Moist Heat or Steam Sterilization

[07899995274670]

Moist Heat or Steam Sterilization

[07899995274670]

Moist Heat or Steam Sterilization

[07899995274670]

Moist Heat or Steam Sterilization

[07899995274670]

Moist Heat or Steam Sterilization

[07899995274670]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-29
• Device Publish Date: 2023-06-21

Devices Manufactured by Sin Sistema de Implante Nacional S/A

• 07899995240507 - DIRECTION INDICATOR ANGLED 52°: 2025-12-04 DIRECTION INDICATOR ANGLED 52°
• 07899995241108 - BioHorizons: 2025-12-03 REMOTE ANCHORAGE SURGICAL TRAY
• 07899995243140 - BioHorizons: 2025-12-03 MANUAL DRIVER HANDLE
• 07899995243157 - BioHorizons: 2025-12-03 ZYGOMA DEPTH PROBE
• 07899995243164 - BioHorizons: 2025-12-03 TORQUE WRENCH 4MM SQUARE 80NCM
• 07899995243225 - BioHorizons: 2025-12-03 RATCHET .050 HEX DRIVER
• 07899995243232 - BioHorizons: 2025-12-03 MANUAL .050 HEX DRIVER
• 07899995243263 - BioHorizons: 2025-12-03 HANDPIECE .050 HEX DRIVER