VALO GRAND 4666-

GUDID 00883205026033

VALO GRAND Barrier Sleeve

ULTRADENT PRODUCTS, INC.

Medical equipment handle cover, single-use, non-sterile

• Primary Device ID: 00883205026033
• NIH Device Record Key: d1fab58e-0db4-46d9-b0cb-127969ce756f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VALO GRAND
• Version Model Number: 4666-
• Catalog Number: 4666-
• Company DUNS: 013369913
• Company Name: ULTRADENT PRODUCTS, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205026033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132953

FDA Product Code

• PEM: Dental barriers and sleeves

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-06-13

On-Brand Devices [VALO GRAND]

• 00883205101525: VALO GRAND Cordless Light Shield
• 00883205026033: VALO GRAND Barrier Sleeve