SprintRay Nightguard Flex 2 - Simply Clear - 1 Kg

GUDID 00850039704628

SprintRay NightGuard Flex 2 is indicated for the fabrication of dental appliances such as mouthguards and nightguards.

Sprintray, Inc.

Dental appliance fabrication material, resin

• Primary Device ID: 00850039704628
• NIH Device Record Key: 78724dd3-1331-4f95-a04a-648f5514baa5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SprintRay Nightguard Flex 2 - Simply Clear - 1 Kg
• Version Model Number: SRI-0202145
• Company DUNS: 063005260
• Company Name: Sprintray, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com

Device Dimensions

• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram
• Weight: 1 Kilogram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store NightGuard Flex 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use.
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850039704628 [Primary]

FDA Product Code

• KMY: Positioner, Tooth, Preformed

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-01
• Device Publish Date: 2024-03-22

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