TruFit 2.0

GUDID 00190730054869

TruFit 2.0 ASM .018 ROTH UR6 NC OCBT -10T 8DOff CLT 36.5 (3PK)

ORTHO TECHNOLOGY, INC.

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Primary Device ID00190730054869
NIH Device Record Key2cf94e21-a908-4f38-becf-0734364341ef
Commercial Distribution Discontinuation2021-09-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTruFit 2.0
Version Model Number493-11-1682-365
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
GS100190730054869 [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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