Detail Pliers

GUDID 00816063022008

Pliers

Align Technology, Inc.

Orthodontic pliers Orthodontic pliers Orthodontic pliers Orthodontic pliers Orthodontic pliers Orthodontic pliers Orthodontic pliers Orthodontic pliers Orthodontic pliers Orthodontic pliers Orthodontic pliers 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.

• 00816063022138 - iTero Lumina Scanning Unit: 2024-02-23 Scanning unit (wand)
• 00816063021421 - iTero Lumina Cart upgrade from Element Plus: 2024-02-09 Upgrade kit for existing iTero users who upgrade their Plus scanner to Lumina scanner
• 00816063021438 - iTero Lumina Mobile Configuration: 2024-02-09 iTero Lumina Intraoral scanner Mobile Configuration
• 00816063021452 - iTero Lumina DOA Cart: 2024-02-09 Replacement package of iTero Lumina scanner in case of DOA
• 00816063021469 - iTero Lumina RMA Scanning Unit: 2024-02-09 Scanning unit (wand) replacement package
• 00816063021483 - iTero Lumina 25 Disposable Sleeves Box: 2024-02-09 Disposable single use sleeves box
• 00816063021599 - iTero Lumina scanning unit: 2024-02-09 Scanning unit (wand)
• 00816063021841 - iTero Lumina RMA, PPC Unit: 2024-02-09 Replacement package of cart computing unit - iTero Lumina