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 ID00190730052025
NIH Device Record Key4b819c5b-5c10-46fc-952d-a7f8d8a61e92
Commercial Distribution Discontinuation2021-09-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTruFit 2.0
Version Model Number491-92-4620-295
Company DUNS781772017
Company NameORTHO TECHNOLOGY, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190730052025 [Primary]

FDA Product Code

ECMBAND, PREFORMED, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-09-14
Device Publish Date2021-08-31

On-Brand Devices [TruFit 2.0]

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

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