Maxima Radiopaque Kit 2283013

GUDID 10304040000868

Maxima Radiopaque Kit

HENRY SCHEIN, INC.

Resin artificial teeth

• Primary Device ID: 10304040000868
• NIH Device Record Key: 850585ba-d6c4-4344-8cde-058c3c6378d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maxima Radiopaque Kit
• Version Model Number: 2283013
• Catalog Number: 2283013
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, 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: true
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product in a cool and dry area
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product in a cool and dry area
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product in a cool and dry area
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product in a cool and dry area
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product in a cool and dry area
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product in a cool and dry area
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product in a cool and dry area
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product in a cool and dry area
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product in a cool and dry area
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040000861 [Primary]
GS1	10304040000868 [Package]; Contains: 00304040000861; Package: KIT [13 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102874

FDA Product Code

• ELM: Denture, plastic, teeth

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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• 00304040177860 - Henry Schein: 2025-03-13 HS Disposable Biopsy Punch, 3.5mm 25ea/bx
• 00304040177877 - Henry Schein: 2025-03-13 HS Disposable Biopsy Punch, 4.0mm 25ea/bx
• 00304040177884 - Henry Schein: 2025-03-13 HS Disposable Biopsy Punch, 5.0mm 25ea/bx