Avalon Biomed by Zarc Z-Fit Gutta Percha - Narrow 15

GUDID 00810118105630

60 units

NUSMILE, LTD.

Natural gutta-percha

• Primary Device ID: 00810118105630
• NIH Device Record Key: 1eb8200c-8b0f-44d0-97a4-1b976a01d4fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avalon Biomed by Zarc Z-Fit Gutta Percha - Narrow 15
• Version Model Number: GP-701
• Company DUNS: 185497372
• Company Name: NUSMILE, LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810118105630 [Primary]

FDA Product Code

• EKM: Gutta-Percha

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: 2025-02-06
• Device Publish Date: 2025-01-29

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• 00810118103698 - NuSmile NuNamel Varnish: 2025-03-26 NuSmile NuNamel Varnish Unit Dose 200 pk Kit - Strawberry
• 00810118103704 - NuSmile NuNamel Varnish: 2025-03-26 NuSmile NuNamel Varnish Unit Dose 200 pk Kit - Mint
• 00810118103711 - NuSmile NuNamel Varnish: 2025-03-26 NuSmile NuNamel Varnish Unit Dose 200 pk Kit - Bubblegum