Avalon Biomed by Zarc SlimShaper Paper Point ZS1

GUDID 00810118104312

Avalon Biomed by Zarc SlimShaper Paper Point ZS1

NUSMILE, LTD.

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• Primary Device ID: 00810118104312
• NIH Device Record Key: 0c913dc3-6ff5-4bd8-9278-0a2de967eedb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avalon Biomed by Zarc SlimShaper Paper Point ZS1
• Version Model Number: PP-201
• 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: 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

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
• 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	00810118104312 [Primary]

FDA Product Code

• EKN: Point, Paper, Endodontic

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: 2024-02-07
• Device Publish Date: 2024-01-30

Devices Manufactured by NUSMILE, LTD.

• 00810118104350 - Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1): 2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1)
• 00810118104367 - Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS2): 2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS2)
• 00810118104374 - Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS3): 2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS3)
• 00810118104381 - Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1-ZS3): 2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1-ZS3)
• 00810118104398 - Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1): 2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1)
• 00810118104404 - Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS2): 2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS2)
• 00810118104411 - Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS3): 2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS3)
• 00810118104428 - Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1-ZS3): 2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1-ZS3)