Stratosphere 1005748

GUDID H65810057481

Stratosphere 1 Spill 400mg Fast Set 50 jar

HENRY SCHEIN, INC.

Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam

• Primary Device ID: H65810057481
• NIH Device Record Key: b6ba56b0-6fa7-48f6-b48a-7d52d3e2ba70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stratosphere
• Version Model Number: 1005748
• Catalog Number: 1005748
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 50
• 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

• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram

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	H65810057481 [Primary]
HIBCC	H65810057488 [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]

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• 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