Dolphin Blue Imaging 2.0

GUDID 00350227000445

PATTERSON DENTAL SUPPLY, INC.

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• Primary Device ID: 00350227000445
• NIH Device Record Key: 0296601a-4f1a-45d7-b1a6-7157e0d80a86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dolphin Blue Imaging 2.0
• Version Model Number: 2.0
• Company DUNS: 171843584
• Company Name: PATTERSON DENTAL SUPPLY, 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00350227000445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221478

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2023-07-26
• Device Publish Date: 2023-07-18

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