Easter Self-Ligating Bracket,.022 Roth, #3 w/hs

GUDID 86941673515968

Astar Orthodontics Inc.

Orthodontic bracket, metal

• Primary Device ID: 86941673515968
• NIH Device Record Key: b0567a52-9e9c-4fcd-a240-2da4b05685e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easter Self-Ligating Bracket,.022 Roth, #3 w/hs
• Version Model Number: 1831-011
• Company DUNS: 547794613
• Company Name: Astar Orthodontics Inc.
• Device Count: 50
• 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: true
• 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	06941673515962 [Primary]
GS1	86941673515968 [Unit of Use]

FDA Product Code

• EJF: Bracket, Metal, Orthodontic

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: 2024-01-08
• Device Publish Date: 2023-12-31

On-Brand Devices [Easter Self-Ligating Bracket,.022 Roth, #3 w/hs ]

• 06973329322082: 1831-55-3H
• 86941673515968: 1831-011