Direct Bond Retainer

GUDID 00190707096984

3 x 3 Direct Bond Retainer - 22mm

Ortho Organizers, Inc.

Orthodontic retainer
Primary Device ID00190707096984
NIH Device Record Key0916154f-da49-43f7-9c9b-6bb88803609a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirect Bond Retainer
Version Model Number433-022
Company DUNS062165188
Company NameOrtho Organizers, 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
GS100190707096984 [Primary]

FDA Product Code

EJFBRACKET, METAL, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-12-19
Device Publish Date2022-01-06

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