Burkhart Polar Breeze Refrigerant Spray 6oz

GUDID 00854212006561

BURKHART DENTAL SUPPLY CO., THE

Cryogenic spray, dental

• Primary Device ID: 00854212006561
• NIH Device Record Key: 33efff10-f4a8-4b6e-8997-afaeb47f6760
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Burkhart Polar Breeze Refrigerant Spray 6oz
• Version Model Number: 72720585
• Company DUNS: 027532357
• Company Name: BURKHART DENTAL SUPPLY CO., THE
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800)562-8176
• Email: customerservice@burkhartdental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854212006561 [Primary]
GS1	10854212006568 [Package]; Package: [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: 2016-09-16

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