SURGICAL KIT KTMEC 02

GUDID 07899995209511

PROSTHETIC KIT

Sin Sistema de Implante Nacional S/A

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

• Primary Device ID: 07899995209511
• NIH Device Record Key: c7b78ec3-8fdb-4e43-8d42-a719498f6793
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGICAL KIT
• Version Model Number: KTMEC 02
• Catalog Number: KTMEC 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: false
• 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	07899995209511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201688

FDA Product Code

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

Sterilization

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

[07899995209511]

Moist Heat or Steam Sterilization

[07899995209511]

Moist Heat or Steam Sterilization

[07899995209511]

Moist Heat or Steam Sterilization

[07899995209511]

Moist Heat or Steam Sterilization

[07899995209511]

Moist Heat or Steam Sterilization

[07899995209511]

Moist Heat or Steam Sterilization

[07899995209511]

Moist Heat or Steam Sterilization

[07899995209511]

Moist Heat or Steam Sterilization

[07899995209511]

Moist Heat or Steam Sterilization

[07899995209511]

Moist Heat or Steam Sterilization

[07899995209511]

Moist Heat or Steam Sterilization

[07899995209511]

Moist Heat or Steam Sterilization

[07899995209511]

Moist Heat or Steam Sterilization

[07899995209511]

Moist Heat or Steam Sterilization

[07899995209511]

Moist Heat or Steam Sterilization

[07899995209511]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-08
• Device Publish Date: 2021-03-31

On-Brand Devices [SURGICAL KIT]

• 07899995299949: SURGICAL KIT UNITITE
• 07899995299932: GUIDED SURGERY KIT UNITITE
• 07899995299918: GUIDED SURGERY KIT STRONG SW
• 07899995294555: KIT SAFE DRILL
• 07899995294548: KIT SAFE DRILL SW
• 07899995293565: SURGERY KIT TRYON
• 07899995271471: SURGICAL KIT TRYON
• 07899995269942: KIT SINUS LIFTING
• 07899995209528: SURGICAL KIT ZYGOMATIC
• 07899995209511: PROSTHETIC KIT
• 07899995209412: KITS OSTEOTOMER RUMMERR C/STOP
• 07899995209368: KIT BONE EXPANDER WITH STOPPER
• 07899995209306: SURGICAL KIT STRONG SW
• 07899995209290: KIT ROTARY EXPANDER