Easter S.L Bracket, .022 Roth, UL5, w/o hook

GUDID 86941673516019

Astar Orthodontics Inc.

Orthodontic bracket, metal

• Primary Device ID: 86941673516019
• NIH Device Record Key: e6ce152d-d680-48a4-9728-2daf6c339b78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easter S.L Bracket, .022 Roth, UL5, w/o hook
• Version Model Number: 1831-015
• 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	06941673516013 [Primary]
GS1	86941673516019 [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

Devices Manufactured by Astar Orthodontics Inc.

• 86941673501459 - Thino Roth Bracket, .022, Mini Size, UL1: 2024-01-08
• 86941673501466 - Thino Roth Bracket, .022, Mini Size, UL2: 2024-01-08
• 86941673501473 - Thino Roth Bracket, .022 Mini, UL3, w/hk at distal: 2024-01-08
• 86941673501480 - Thino Roth Bracket, .022 Mini, UL4, w/o hook: 2024-01-08
• 86941673501497 - Thino Roth Bracket, .022 Mini, UL4, w/hk at mesial: 2024-01-08
• 86941673501503 - Thino Roth Bracket, .022 Mini, UL4, w/hk at distal: 2024-01-08
• 86941673501510 - Thino Roth Bracket, .022 Mini, UL5, w/o hook: 2024-01-08
• 86941673501527 - Thino Roth Bracket, .022 Mini, UL5, w/hk at mesial: 2024-01-08