Low Speed Handpiece Sleeve

GUDID 20302736704509

YOUNG DENTAL MANUFACTURING I, LLC

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• Primary Device ID: 20302736704509
• NIH Device Record Key: 93de25e6-cd83-48ed-ac2b-c2d426217c7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Low Speed Handpiece Sleeve
• Version Model Number: 670450
• Company DUNS: 006309355
• Company Name: YOUNG DENTAL MANUFACTURING I, LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10302736704502 [Primary]
GS1	20302736704509 [Package]; Contains: 10302736704502; Package: Box [500 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151123

FDA Product Code

• PEM: Dental Barriers And Sleeves

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: 2020-02-10
• Device Publish Date: 2017-10-27

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