Bracketizer Instrument

GUDID 00190707102388

Bracketizer Instrument

ORTHO ORGANIZERS, INC.

Orthodontic pliers

• Primary Device ID: 00190707102388
• NIH Device Record Key: 8befeffc-c423-43fe-80c1-0d47607675e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bracketizer Instrument
• Version Model Number: 200-329
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Manufacturing Date: false
• 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	00190707102388 [Primary]

FDA Product Code

• ECQ: ALIGNER, BRACKET, 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: 2022-10-25
• Device Publish Date: 2022-10-17

Devices Manufactured by ORTHO ORGANIZERS, INC.

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• 10190707115156 - TruFit™ 2.0: 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 32.0 (3PK)
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• 10190707115170 - TruFit™ 2.0: 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 33.0 (3PK)