VALO™ Barrier Sleeves 5898

GUDID 07350069422842

Barrier sleeves protect your VALO™ curing light from coming into direct contact with the patient's tissues, as well as etchants and other chemistry, and are highly important for keeping your VALO curing light sanitary. Barrier sleeves are available in three sizes to fit VALO™ X, VALO™ Grand, and VALO™ Corded/Cordless curing lights. Prevents direct contact between your VALO curing light and the patient’s tissues Protects your VALO curing light from direct contact with etchants and other chemistry Important for maintaining sanitary conditions Available in three sizes

Minitube AB

Medical equipment drape, single-use

• Primary Device ID: 07350069422842
• NIH Device Record Key: 2457bd1d-6484-4382-a555-e86181c91360
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VALO™ Barrier Sleeves
• Version Model Number: VALO X 600 Barrier Sleeves Refill
• Catalog Number: 5898
• Company DUNS: 775295061
• Company Name: Minitube AB
• Device Count: 300
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350069420848 [Unit of Use]
GS1	07350069421845 [Primary]
GS1	07350069422842 [Package]; Contains: 07350069421845; Package: Wrapped bundle [2 Units]; In Commercial Distribution

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: 2024-05-09
• Device Publish Date: 2024-05-01

On-Brand Devices [VALO™ Barrier Sleeves]

• 07350069422859: Barrier sleeves protect your VALO™ curing light from coming into direct contact with the patie
• 07350069422842: Barrier sleeves protect your VALO™ curing light from coming into direct contact with the patie
• 07350069422835: Barrier sleeves protect your VALO™ curing light from coming into direct contact with the patie