KIT SAFE DRILL KESD 02

GUDID 07899995265845

KIT SAFE DRILL

Sin Sistema de Implante Nacional S/A

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

• Primary Device ID: 07899995265845
• NIH Device Record Key: 543421ba-506e-4085-a449-5a1c21f44941
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIT SAFE DRILL
• Version Model Number: KESD 02
• Catalog Number: KESD 02
• 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	07899995265845 [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

[07899995265845]

Moist Heat or Steam Sterilization

[07899995265845]

Moist Heat or Steam Sterilization

[07899995265845]

Moist Heat or Steam Sterilization

[07899995265845]

Moist Heat or Steam Sterilization

[07899995265845]

Moist Heat or Steam Sterilization

[07899995265845]

Moist Heat or Steam Sterilization

[07899995265845]

Moist Heat or Steam Sterilization

[07899995265845]

Moist Heat or Steam Sterilization

[07899995265845]

Moist Heat or Steam Sterilization

[07899995265845]

Moist Heat or Steam Sterilization

[07899995265845]

Moist Heat or Steam Sterilization

[07899995265845]

Moist Heat or Steam Sterilization

[07899995265845]

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

• 07899995238146 - SURGICAL INSTRUMENT: 2025-09-15 DRIVER EXTENSOR OF DRILL
• 07899995239457 - VERSALIS S: 2025-08-26 IMP. VERSALIS S MT16° Ø5.0X11.5MM
• 07899995239488 - VERSALIS S PLUS: 2025-08-26 IMP. VERSALIS S PLUS MT16° Ø4.0X20MM
• 07899995239495 - VERSALIS S PLUS: 2025-08-26 IMP. VERSALIS S PLUS MT16° Ø7.0X13MM
• 07899995239501 - VERSALIS S PLUS: 2025-08-26 IMP. VERSALIS S PLUS MT16° Ø7.0X11.5MM
• 07899995239518 - VERSALIS S PLUS: 2025-08-26 IMP. VERSALIS S PLUS MT16° Ø7.0X10MM
• 07899995239525 - VERSALIS S PLUS: 2025-08-26 IMP. VERSALIS S PLUS MT16° Ø7.0X8.5MM
• 07899995239532 - VERSALIS S PLUS: 2025-08-26 IMP. VERSALIS S PLUS MT16° Ø6.0X13MM