Toothette Oral Care 4000

GUDID 50618029810323

Disposable Bite Block for Oral Control

SAGE PRODUCTS, LLC

Mouthguard, single-use

• Primary Device ID: 50618029810323
• NIH Device Record Key: 959d46ce-8f48-42cd-894d-b185e7083744
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Toothette Oral Care
• Version Model Number: 4000
• Catalog Number: 4000
• Company DUNS: 054326178
• Company Name: SAGE PRODUCTS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)323-2220
• Email: customer-service-spcl@sageproducts.com
• Phone: +1(800)323-2220
• Email: customer-service-spcl@sageproducts.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618029810328 [Primary]
GS1	50618029810323 [Package]; Contains: 00618029810328; Package: case [144 Units]; In Commercial Distribution

FDA Product Code

• BRW: PROTECTOR, DENTAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-24
• Device Publish Date: 2016-09-24

On-Brand Devices [Toothette Oral Care]

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• 50618029821343: Q4 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
• 50618029821336: Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
• 50618029821176: Untreated Suction Toothbrush, Suction Swab, and Applicator Swab
• 50618029821169: Suction Toothbrush with Perox-A-Mint Solution and Mouth Moisturizer
• 50618029821152: Suction Swab System with Perox-A-Mint Solution
• 50618029821107: Oral Hygiene Kit, Suction Brush with Antiseptic Oral Rinse and Mouth Moisturizer
• 50618029821053: Suction Toothbrush with Perox-A-Mint Solution
• 50618029821008: Oral Hygiene Kit, Suction Swabs with Antiseptic Oral Rinse and Mouth Moisturizer
• 50618029820971: Suction Toothbrushes with Perox-A-Mint Solution
• 50618029810323: Disposable Bite Block for Oral Control
• 50618029800652: Suction Swab System with Perox-A-Mint Solution
• 50618029800645: Suction Swabs with Perox-A-Mint Solution and Mouth Moisturizer
• 50618029800638: Suction Swabs with Perox-A-Mint Solution
• 50618029800607: Q2 Oral Cleansing & Suctioning System
• 50618029830512: Sales Demonstration Sample- Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluco