TruFit™ 2.0

GUDID 10190707115156

TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 32.0 (3PK)

ORTHO ORGANIZERS, INC.

Orthodontic metal band

• Primary Device ID: 10190707115156
• NIH Device Record Key: 6f34d94b-8678-493a-9655-d0fb69426199
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruFit™ 2.0
• Version Model Number: 491-11-1610-320-3
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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	00190707115159 [Primary]
GS1	10190707115156 [Unit of Use]

FDA Product Code

• ECM: BAND, PREFORMED, 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: 2025-10-07
• Device Publish Date: 2025-09-29

On-Brand Devices [TruFit™ 2.0]

• 10190707120044: TruFit™ 2.0 ASM .018 ROTH LR6 CONV SBT -25T 4DOff CLT 30.0 (3PK)
• 10190707120037: TruFit™ 2.0 ASM .018 ROTH LR6 CONV SBT -25T 4DOff CLT 29.5 (3PK)
• 10190707120020: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 44.0 (3PK)
• 10190707120013: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 43.5 (3PK)
• 10190707120006: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 43.0 (3PK)
• 10190707119994: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 42.5 (3PK)
• 10190707119987: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 42.0 (3PK)
• 10190707119970: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 41.5 (3PK)
• 10190707119963: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 41.0 (3PK)
• 10190707119956: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 40.5 (3PK)
• 10190707119949: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 40.0 (3PK)
• 10190707119932: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 39.5 (3PK)
• 10190707119925: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 39.0 (3PK)
• 10190707119918: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 38.5 (3PK)
• 10190707119901: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 38.0 (3PK)
• 10190707119895: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 37.0 (3PK)
• 10190707119888: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 36.5 (3PK)
• 10190707119871: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 34.5 (3PK)
• 10190707119864: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 34.0 (3PK)
• 10190707119857: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 33.5 (3PK)
• 10190707119840: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 32.5 (3PK)
• 10190707119833: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 32.0 (3PK)
• 10190707119826: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 30.5 (3PK)
• 10190707119819: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 30.0 (3PK)
• 10190707119802: TruFit™ 2.0 ASM .022 ROTH LR7 NC SBT -25T 4DOff 29.5 (3PK)
• 10190707119796: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 44.0 (3PK)
• 10190707119789: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 43.5 (3PK)
• 10190707119772: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 43.0 (3PK)
• 10190707119765: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 42.5 (3PK)
• 10190707119758: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 42.0 (3PK)
• 10190707119741: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 41.5 (3PK)
• 10190707119734: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 41.0 (3PK)
• 10190707119727: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 40.5 (3PK)
• 10190707119710: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 40.0 (3PK)
• 10190707119703: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 39.5 (3PK)
• 10190707119697: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 39.0 (3PK)
• 10190707119680: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 38.5 (3PK)
• 10190707119673: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 37.5 (3PK)
• 10190707119666: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 35.5 (3PK)
• 10190707119659: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 35.0 (3PK)
• 10190707119642: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 34.0 (3PK)
• 10190707119635: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 33.5 (3PK)
• 10190707119628: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 33.0 (3PK)
• 10190707119611: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 32.5 (3PK)
• 10190707119604: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 32.0 (3PK)
• 10190707119598: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 31.5 (3PK)
• 10190707119581: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 31.0 (3PK)
• 10190707119574: TruFit™ 2.0 ASM .022 ROTH LR6 CONV DBT -25T 4DOff 30.5 (3PK)
• 10190707119567: TruFit™ 2.0 ASM .022 ROTH LR6 NC SBT -25T 4DOff 44.0 (3PK)
• 10190707119550: TruFit™ 2.0 ASM .022 ROTH LR6 NC SBT -25T 4DOff 43.5 (3PK)