Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1-ZS3)

GUDID 00810118104381

Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1-ZS3)

NUSMILE, LTD.

Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: 00810118104381
• NIH Device Record Key: e58218c6-dffe-458f-bdcb-984e1dfeb378
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1-ZS3)
• Version Model Number: ZSS21APRO6
• Company DUNS: 185497372
• Company Name: NUSMILE, LTD.
• Device Count: 1
• DM Exempt: false
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810118104381 [Primary]

FDA Product Code

• EKS: File, Pulp Canal, 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: 2024-02-20
• Device Publish Date: 2024-02-12

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): 2024-02-20Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1-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)