Ionosphere 1008191

GUDID H65810081911

Ionosphere Powder Fast Set 5 Toz Pkg

HENRY SCHEIN, INC.

Dental amalgam

• Primary Device ID: H65810081911
• NIH Device Record Key: b242a311-ef42-46a0-bc9a-8180ce4affcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ionosphere
• Version Model Number: 1008191
• Catalog Number: 1008191
• 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

• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H65810081911 [Primary]
HIBCC	H65810081918 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K821222

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 [Ionosphere]

• H65810091251: Ionosphere Tablets Fast Set 5 Toz Pkg
• H65810090501: Ionosphere Tablets Regular Set 5 Toz Pkg
• H65810081911: Ionosphere Powder Fast Set 5 Toz Pkg
• H65810081821: Ionosphere 3 Spill 800mg Fast Set 500 jar
• H65810072111: Ionosphere 3 Spill 800mg Fast Set 50 jar
• H65810060371: Ionosphere 1 Spill 400mg Fast Set 500 jar
• H65810059661: Ionosphere Powder Regular Set 5 Toz Pkg
• H65810039461: Ionosphere 2 Spill 600mg Fast Set 50 jar
• H65810021531: Ionosphere 2 Spill 600mg Fast Set 500 jar
• H65810002251: Ionosphere 1 Spill 400mg Fast Set 50 jar