SURGICAL KIT UNITITE KCSU 04

GUDID 07899995200105

SURGICAL KIT UNITITE

Sin Sistema de Implante Nacional S/A

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

• Primary Device ID: 07899995200105
• NIH Device Record Key: a14af2d1-9d6d-4dbb-ad90-d8357b8cabfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGICAL KIT UNITITE
• Version Model Number: KCSU 04
• Catalog Number: KCSU 04
• 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	07899995200105 [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

[07899995200105]

Moist Heat or Steam Sterilization

[07899995200105]

Moist Heat or Steam Sterilization

[07899995200105]

Moist Heat or Steam Sterilization

[07899995200105]

Moist Heat or Steam Sterilization

[07899995200105]

Moist Heat or Steam Sterilization

[07899995200105]

Moist Heat or Steam Sterilization

[07899995200105]

Moist Heat or Steam Sterilization

[07899995200105]

Moist Heat or Steam Sterilization

[07899995200105]

Moist Heat or Steam Sterilization

[07899995200105]

Moist Heat or Steam Sterilization

[07899995200105]

Moist Heat or Steam Sterilization

[07899995200105]

Moist Heat or Steam Sterilization

[07899995200105]

Moist Heat or Steam Sterilization

[07899995200105]

Moist Heat or Steam Sterilization

[07899995200105]

Moist Heat or Steam Sterilization

[07899995200105]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-22
• Device Publish Date: 2023-06-14

On-Brand Devices [SURGICAL KIT UNITITE]

• 07899995200105: SURGICAL KIT UNITITE
• 07899995264824: SURGICAL KIT UNITITE