iTero Element Scanner Sleeve (25pcs/Box)

GUDID 00816063020585

Scanner Sleeve

ALIGN TECHNOLOGY, INC.

Dental CAD/CAM system, chairside

• Primary Device ID: 00816063020585
• NIH Device Record Key: 4093e94d-f1c7-4427-8348-88765d96f110
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTero Element Scanner Sleeve (25pcs/Box)
• Version Model Number: 109236
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816063020585 [Primary]

FDA Product Code

• NOF: System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

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: 2020-06-12
• Device Publish Date: 2020-06-04

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