Avalon Biomed by Zarc BlueShaper PRO File 16mm (ZXS)

GUDID 00810118104527

Avalon Biomed by Zarc BlueShaper PRO File 16mm (ZXS)

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

• Primary Device ID: 00810118104527
• NIH Device Record Key: 067d0244-9f8f-48e7-8eb1-d80256898f55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avalon Biomed by Zarc BlueShaper PRO File 16mm (ZXS)
• Version Model Number: ZBS16PROZX
• 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
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810118104527 [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: 2024-05-28
• Device Publish Date: 2024-05-20

Devices Manufactured by NUSMILE, LTD.

• 00810118104565 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 1 Right - Regular Length / Light Shade
• 00810118104572 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 2 Right - Regular Length / Light Shade
• 00810118104589 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 3 Right - Regular Length / Light Shade
• 00810118104596 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 4 Right - Regular Length / Light Shade
• 00810118104602 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 5 Right - Regular Length / Light Shade
• 00810118104619 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 6 Right - Regular Length / Light Shade
• 00810118104626 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 1 Left - Regular Length / Light Shade
• 00810118104633 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 2 Left - Regular Length / Light Shade