Invisalign EZ-Trim Polishing Wheel

GUDID 00850042861257

Align Technology, Inc.

Orthodontic pliers

• Primary Device ID: 00850042861257
• NIH Device Record Key: 661aca01-e2d7-43e2-8463-1c80bba70ac1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invisalign EZ-Trim Polishing Wheel
• Version Model Number: 100046
• Company DUNS: 013831768
• Company Name: Align Technology, Inc.
• 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: false
• Lot Batch: true
• Serial Number: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850042861257 [Primary]

FDA Product Code

• EJQ: Wheel, Polishing Agent

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00850042861257]

High-level Disinfectant

[00850042861257]

High-level Disinfectant

[00850042861257]

High-level Disinfectant

[00850042861257]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

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