Young Dental, Infinity

GUDID 00816577024598

Sleeve for Infinity, 25ct (Purchase Only When Ordered by W&H)

YOUNG DENTAL MANUFACTURING I, LLC

Medical equipment/instrument drape, single-use

• Primary Device ID: 00816577024598
• NIH Device Record Key: a06fc6b3-ceb7-4644-9b10-55f5653195d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Young Dental, Infinity
• Version Model Number: 295830
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816577024598 [Primary]
GS1	10816577024595 [Package]; Package: Inner Pack [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233918

FDA Product Code

• PEM: Dental Barriers And Sleeves

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: 2024-10-08
• Device Publish Date: 2024-09-30

On-Brand Devices [Young Dental, Infinity]

• 00816577024598: Sleeve for Infinity, 25ct (Purchase Only When Ordered by W&H)
• 10816577024588: Barrier Sleeve, Young Infinity Cordless Handpiece, 500ct