NuSmile NeoLINER LC Sample Pack (1 g Syringe + 5 Tips, No IFU)

GUDID 00810118103995

NuSmile NeoLINER LC Sample Pack (1 g Syringe + 5 Tips, No IFU)

NUSMILE, LTD.

Dental composite resin

• Primary Device ID: 00810118103995
• NIH Device Record Key: 6d5cee18-dc4b-4296-8f6c-cf70dee56efe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuSmile NeoLINER LC Sample Pack (1 g Syringe + 5 Tips, No IFU)
• Version Model Number: NNLSP
• Company DUNS: 185497372
• Company Name: NUSMILE, LTD.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810118103995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202413

FDA Product Code

• EJK: Liner, Cavity, Calcium Hydroxide

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: 2023-12-08
• Device Publish Date: 2023-11-30

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