TruFit 2.0

GUDID 00190730052025

*TruFit 2.0 ASM .022 ROTH LL6 NC SBT -25T 4DOff 29.5 (3PK)

ORTHO TECHNOLOGY, INC.

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• Primary Device ID: 00190730052025
• NIH Device Record Key: 4b819c5b-5c10-46fc-952d-a7f8d8a61e92
• Commercial Distribution Discontinuation: 2021-09-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TruFit 2.0
• Version Model Number: 491-92-4620-295
• Company DUNS: 781772017
• Company Name: ORTHO TECHNOLOGY, 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: 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	00190730052025 [Primary]

FDA Product Code

• ECM: BAND, PREFORMED, ORTHODONTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-09-14
• Device Publish Date: 2021-08-31

On-Brand Devices [TruFit 2.0]

• 00190730083210: TruFit 2.0 Molar Band LL6 Size: 44 (3PK)
• 00190730083203: TruFit 2.0 Molar Band LL6 Size: 43.5 (3PK)
• 00190730083197: TruFit 2.0 Molar Band LL6 Size: 43 (3PK)
• 00190730083180: TruFit 2.0 Molar Band LL6 Size: 42.5 (3PK)
• 00190730083173: TruFit 2.0 Molar Band LL6 Size: 42 (3PK)
• 00190730083166: TruFit 2.0 Molar Band LL6 Size: 41.5 (3PK)
• 00190730083159: TruFit 2.0 Molar Band LL6 Size: 41 (3PK)
• 00190730083142: TruFit 2.0 Molar Band LL6 Size: 40.5 (3PK)
• 00190730083135: TruFit 2.0 Molar Band LL6 Size: 40 (3PK)
• 00190730083128: TruFit 2.0 Molar Band LL6 Size: 39.5 (3PK)
• 00190730083111: TruFit 2.0 Molar Band LL6 Size: 39 (3PK)
• 00190730083104: TruFit 2.0 Molar Band LL6 Size: 38.5 (3PK)
• 00190730083098: TruFit 2.0 Molar Band LL6 Size: 38 (3PK)
• 00190730083081: TruFit 2.0 Molar Band LL6 Size: 37.5 (3PK)
• 00190730083074: TruFit 2.0 Molar Band LL6 Size: 37 (3PK)
• 00190730083067: TruFit 2.0 Molar Band LL6 Size: 36.5 (3PK)
• 00190730083050: TruFit 2.0 Molar Band LL6 Size: 36 (3PK)
• 00190730083043: TruFit 2.0 Molar Band LL6 Size: 35.5 (3PK)
• 00190730083036: TruFit 2.0 Molar Band LL6 Size: 35 (3PK)
• 00190730083029: TruFit 2.0 Molar Band LL6 Size: 34.5 (3PK)
• 00190730083012: TruFit 2.0 Molar Band LL6 Size: 34 (3PK)
• 00190730083005: TruFit 2.0 Molar Band LL6 Size: 33.5 (3PK)
• 00190730082992: TruFit 2.0 Molar Band LL6 Size: 33 (3PK)
• 00190730082985: TruFit 2.0 Molar Band LL6 Size: 32.5 (3PK)
• 00190730082978: TruFit 2.0 Molar Band LL6 Size: 32 (3PK)
• 00190730082961: TruFit 2.0 Molar Band LL6 Size: 31.5 (3PK)
• 00190730082954: TruFit 2.0 Molar Band LL6 Size: 31 (3PK)
• 00190730082947: TruFit 2.0 Molar Band LL6 Size: 30.5 (3PK)
• 00190730082930: TruFit 2.0 Molar Band LL6 Size: 30 (3PK)
• 00190730082923: TruFit 2.0 Molar Band LL6 Size: 29.5 (3PK)
• 00190730082916: TruFit 2.0 Molar Band LR6 Size: 44 (3PK)
• 00190730082909: TruFit 2.0 Molar Band LR6 Size: 43.5 (3PK)
• 00190730082893: TruFit 2.0 Molar Band LR6 Size: 43 (3PK)
• 00190730082886: TruFit 2.0 Molar Band LR6 Size: 42.5 (3PK)
• 00190730082879: TruFit 2.0 Molar Band LR6 Size: 42 (3PK)
• 00190730082862: TruFit 2.0 Molar Band LR6 Size: 41.5 (3PK)
• 00190730082855: TruFit 2.0 Molar Band LR6 Size: 41 (3PK)
• 00190730082848: TruFit 2.0 Molar Band LR6 Size: 40.5 (3PK)
• 00190730082831: TruFit 2.0 Molar Band LR6 Size: 40 (3PK)
• 00190730082824: TruFit 2.0 Molar Band LR6 Size: 39.5 (3PK)
• 00190730082817: TruFit 2.0 Molar Band LR6 Size: 39 (3PK)
• 00190730082800: TruFit 2.0 Molar Band LR6 Size: 38.5 (3PK)
• 00190730082794: TruFit 2.0 Molar Band LR6 Size: 38 (3PK)
• 00190730082787: TruFit 2.0 Molar Band LR6 Size: 37.5 (3PK)
• 00190730082770: TruFit 2.0 Molar Band LR6 Size: 37 (3PK)
• 00190730082763: TruFit 2.0 Molar Band LR6 Size: 36.5 (3PK)
• 00190730082756: TruFit 2.0 Molar Band LR6 Size: 36 (3PK)
• 00190730082749: TruFit 2.0 Molar Band LR6 Size: 35.5 (3PK)
• 00190730082732: TruFit 2.0 Molar Band LR6 Size: 35 (3PK)
• 00190730082725: TruFit 2.0 Molar Band LR6 Size: 34.5 (3PK)