FROST ENDO SPRAY 9547587

GUDID D82795475870

FROST ENDO SPRAY

DARBY DENTAL SUPPLY, LLC

Cryogenic spray, dental

• Primary Device ID: D82795475870
• NIH Device Record Key: 11365ad4-a8ad-45ba-b024-19dc45fbab9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FROST ENDO SPRAY
• Version Model Number: 9547587
• Catalog Number: 9547587
• Company DUNS: 825137818
• Company Name: DARBY DENTAL SUPPLY, LLC
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D82795475870 [Primary]

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: 2016-08-17

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