TruFit 2.0

GUDID 00190730067357

TruFit 2.0 ASM .018 MC LR6 CONV DBT -20T 0Off CLT 31.0 (3PK)

ORTHO TECHNOLOGY, INC.

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Primary Device ID00190730067357
NIH Device Record Keyc1ea2053-d698-41f6-ab88-f947c58ec75a
Commercial Distribution Discontinuation2021-09-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTruFit 2.0
Version Model Number493-21-3631-310
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
GS100190730067357 [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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