Henry Schein 1125056

GUDID H65811250561

Endo Cool Spray

HENRY SCHEIN, INC.

Cryogenic spray, dental

• Primary Device ID: H65811250561
• NIH Device Record Key: fd52e987-f60c-4a8b-abea-474cf224a577
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Henry Schein
• Version Model Number: 1125056
• Catalog Number: 1125056
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 1
• 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: false
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H65811250560 [Primary]
HIBCC	H65811250561 [Package]; Contains: H65811250560; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930764

FDA Product Code

• EAT: Tester, pulp

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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• 10304040054267: Essentials LED Curing Light, Silver
• 10304040054250: Essentials LED Curing Light, Black
• 10304040054243: Essentials LED Curing Light
• 10304040053222: Stadiometer
• 00304040053218: Digital Remote Indicator Scale 500 lb capacity
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• 00304040053171: Digital Wheelchair Scale 1,000 lb capacity
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• 10304040039769: Suture PGA Undyed DS24
• 10304040039752: Suture PGA Undyed PGA T
• 10304040039721: Suture Chromic Gut DSM19
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• 10304040039707: Suture Chromic Gut C-3
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• 10304040039608: Suture PGA PCL Mono DSM13
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• 00304040039519: CENTRIFUGE MIRCROHEMATOCR
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• 10304040039479: Bur Block Plastic 8 Hole
• 10304040039462: Bur Block Plastic 14 Hole
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• 10304040039431: Bur Block Plastic 14 Hole
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• 10304040039417: Bur Block Magnetic 8 Hole
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• 10304040026547: Sharps Container, 8 Gallon Red
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• 00304040023976: Zirlux Temp PMMA 100x20mm
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