STERILIZATION BOX COLEV

GUDID 07899995299871

ORGANIZER BOX SINUS LIFT

Sin Sistema de Implante Nacional S/A

Surgical instrument container system

• Primary Device ID: 07899995299871
• NIH Device Record Key: 2e3e1097-0611-4df3-af90-d5a774878c7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERILIZATION BOX
• Version Model Number: COLEV
• Catalog Number: COLEV
• 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: false
• 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	07899995299871 [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

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

[07899995299871]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-31
• Device Publish Date: 2021-03-23

On-Brand Devices [STERILIZATION BOX]

• 07899995299888: ORGANIZER BOX OSTEOTOMER
• 07899995279996: ORGANIZER BOX ZIGOMATIC
• 07899995269959: ORGANIZER BOX PROSTHETIC
• 07899995206633: ORGANIZER BOX STRONG SW
• 07899995206442: ORGANIZER BOX ROTARY EXPANSION
• 07899995299871: ORGANIZER BOX SINUS LIFT
• 07899995206473: ORGANIZER BOX EXPANDER
• 07899995299840: ORGANIZER BOX UNITITE
• 07899995294111: ORGANIZER BOX TRYON
• 07899995293381: ORGANIZER BOX KIT GUIDE SW
• 07899995293374: ORGANIZER BOX SAFE DRILL
• 07899995279934: ORGANIZER BOX KIT GUIDE UNITITE
• 07899995271853: ORGANIZER BOX TRYON
• 07899995206459: ORGANIZER BOX SAFE DRILL