Medidenta QD-Switch

GUDID 00850046903380

Convert Fixed 4-hole low-speed to a quick disconnect model ***Low Speeds Only***

Medidenta

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• Primary Device ID: 00850046903380
• NIH Device Record Key: 8dce19e3-8a21-47ac-80bc-c156583de809
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medidenta
• Version Model Number: QD-Switch
• Catalog Number: QD-Switch
• Company DUNS: 012401576
• Company Name: Medidenta
• 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: false
• Lot Batch: false
• Serial Number: true
• 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	00850046903380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030603

FDA Product Code

• EGS: Handpiece, Contra- And Right-Angle Attachment, Dental

Sterilization

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

[00850046903380]

Moist Heat or Steam Sterilization

[00850046903380]

Moist Heat or Steam Sterilization

[00850046903380]

Moist Heat or Steam Sterilization

[00850046903380]

Moist Heat or Steam Sterilization

[00850046903380]

Moist Heat or Steam Sterilization

[00850046903380]

Moist Heat or Steam Sterilization

[00850046903380]

Moist Heat or Steam Sterilization

[00850046903380]

Moist Heat or Steam Sterilization

[00850046903380]

Moist Heat or Steam Sterilization

[00850046903380]

Moist Heat or Steam Sterilization

[00850046903380]

Moist Heat or Steam Sterilization

[00850046903380]

Moist Heat or Steam Sterilization

[00850046903380]

Moist Heat or Steam Sterilization

[00850046903380]

Moist Heat or Steam Sterilization

[00850046903380]

Moist Heat or Steam Sterilization

[00850046903380]

Moist Heat or Steam Sterilization

[00850046903380]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-10
• Device Publish Date: 2023-06-30

On-Brand Devices [Medidenta]

• 00850046903380: Convert Fixed 4-hole low-speed to a quick disconnect model ***Low Speeds Only***
• 00850046903373: second half connecting to the supply line (RED)
• 00850046903366: part connecting to the HP (BLUE)
• 00850046903427: motor & nose cone set
• 00850046903410: hygiene motor with quick disconnect feature