Troposphere 1000037

GUDID H65810000371

Troposphere Powder Fine Cut

HENRY SCHEIN, INC.

Dental amalgam

• Primary Device ID: H65810000371
• NIH Device Record Key: 53f7fae5-4e5d-4967-b6fd-347557ee8a17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Troposphere
• Version Model Number: 1000037
• Catalog Number: 1000037
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 5
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H65810000371 [Primary]
HIBCC	H65810000378 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951865

FDA Product Code

• EJJ: Alloy, amalgam

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: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Troposphere]

• H65810092461: Troposphere 2 Spil 600mg 500 jar
• H65810075321: Troposphere 2 Spil 600mg 50 jar
• H65810040171: Troposphere 3 Spil 800mg 500 jar
• H65810037771: Troposphere Tablets Micro Cut
• H65810015281: Troposphere 1 Spil 400mg 500 jar
• H65810012351: Troposphere 3 Spil 800mg 50 jar
• H65810011851: Troposphere Tablets Micro Cut
• H65810011811: Troposphere 1 Spil 400mg 50 jar
• H65810001171: Troposphere Powder Fine Cut
• H65810000371: Troposphere Powder Fine Cut