Stratosphere 1002052

GUDID H65810020521

Stratosphere 2 Spill 600mg Fast Set 500 jar

HENRY SCHEIN, INC.

Dental amalgam

• Primary Device ID: H65810020521
• NIH Device Record Key: db77e621-31d9-4719-8558-ed6566bf004b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stratosphere
• Version Model Number: 1002052
• Catalog Number: 1002052
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 500
• 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: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0

Operating and Storage Conditions

• 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
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H65810020521 [Primary]
HIBCC	H65810020528 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K820617

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 [Stratosphere]

• H65810096471: Stratosphere 2 Spill 600mg Regular Set 500 jar
• H65810095401: Stratosphere 1 Spill 400mg Regular Set 500 jar
• H65810089011: Stratosphere 3 Spill 800mg Regular Set 50 jar
• H65810077651: Stratosphere 1 Spill 400mg Fast Set 500 jar
• H65810077211: Stratosphere 2 Spill 600mg Regular Set 50 jar
• H65810075291: Stratosphere Tablets Fast Set 5 Toz Pkg
• H65810061931: Stratosphere 3 Spill 800mg Fast Set 500 jar
• H65810057481: Stratosphere 1 Spill 400mg Fast Set 50 jar
• H65810054471: Stratosphere 3 Spill 800mg Regular Set 500 jar
• H65810045141: Stratosphere 1 Spill 400mg Regular Set 50 jar
• H65810040021: Stratosphere Powder Fast Set 5 Toz Pkg
• H65810028501: Stratosphere 2 Spill 600mg Fast Set 50 jar
• H65810023621: Stratosphere Powder Regular Set 5 Toz Pkg
• H65810020521: Stratosphere 2 Spill 600mg Fast Set 500 jar
• H65810020491: Stratosphere 3 Spill 800mg Fast Set 50 jar
• H65810007411: Stratosphere Tablets Regular Set 5 Toz Pkg