Detail Pliers

GUDID 00816063022008

Pliers

Align Technology, Inc.

Orthodontic pliers

• Primary Device ID: 00816063022008
• NIH Device Record Key: 09d49953-fa6d-4024-9527-f5de50aad5d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Detail Pliers
• Version Model Number: 100050
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816063020332 [Package]; Package: kit [1 Units]; In Commercial Distribution
GS1	00816063022008 [Primary]

FDA Product Code

• JEX: Plier, Orthodontic

Sterilization

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

[00816063022008]

Moist Heat or Steam Sterilization

[00816063022008]

Moist Heat or Steam Sterilization

[00816063022008]

Moist Heat or Steam Sterilization

[00816063022008]

Moist Heat or Steam Sterilization

[00816063022008]

Moist Heat or Steam Sterilization

[00816063022008]

Moist Heat or Steam Sterilization

[00816063022008]

Moist Heat or Steam Sterilization

[00816063022008]

Moist Heat or Steam Sterilization

[00816063022008]

Moist Heat or Steam Sterilization

[00816063022008]

Moist Heat or Steam Sterilization

[00816063022008]

Moist Heat or Steam Sterilization

[00816063022008]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-14
• Device Publish Date: 2022-12-06

Devices Manufactured by Align Technology, Inc.

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• 00816063022800 - Invisalign Pre-Formed Attachment System: 2025-03-10 The Invisalign Pre-Formed Attachment System is a doctor prescribed, patient specific system for the bonding of 3D-printed attach
• 00816063022213 - iTero Lumina Pro: 2024-11-27 iTero Lumina Pro US Cart Configuration
• 00816063022237 - iTero Lumina Pro Mobile: 2024-11-27 iTero Lumina Pro US Mobile Configuration
• 00816063022268 - iTero Lumina Pro intraoral scanning unit: 2024-11-27 iTero Lumina Pro Scanning Unit, RMA Package US
• 00816063022329 - iTero Lumina Pro DOA: 2024-11-27 iTero Lumina Pro US DOA Kit cart