TruFit 2.0

GUDID 00190730033802

TruFit™2.0 .018 R LL6 CONV LBT -25T 4DO WLD (10PK)

ORTHO TECHNOLOGY, INC.

Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube
Primary Device ID00190730033802
NIH Device Record Key31062a89-26be-41d7-bcd2-8c19246f9aca
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruFit 2.0
Version Model Number490-91-4691
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
GS100190730033802 [Primary]

FDA Product Code

DZDTUBE, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-27
Device Publish Date2021-09-17

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)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.