C20 Intraoral Protective Sheaths

GUDID 07350069421562

Intraoral Protective Sheaths

Minitube AB

Medical equipment/instrument drape, single-use

• Primary Device ID: 07350069421562
• NIH Device Record Key: 622d7d33-3876-4c4f-8ed6-d005b71f31e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C20 Intraoral Protective Sheaths
• Version Model Number: 403061
• Company DUNS: 775295061
• Company Name: Minitube AB
• Device Count: 500
• 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: true
• 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	07350069420565 [Unit of Use]
GS1	07350069421562 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211026

FDA Product Code

• PEM: Dental Barriers And Sleeves

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-09
• Device Publish Date: 2025-04-01

On-Brand Devices [C20 Intraoral Protective Sheaths]

• 07350069420572: C20 Intraoral Protective Sheaths
• 07350069421562: Intraoral Protective Sheaths