Direct Bond Eyelets

GUDID 00190730011718

Round Direct Bond Eyelet 10 per pack

ORTHO TECHNOLOGY, INC.

Orthodontic bracket, metal
Primary Device ID00190730011718
NIH Device Record Keye73549ca-71f1-4a67-b196-82316910e9b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirect Bond Eyelets
Version Model Number025-100
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
GS100190730011718 [Primary]

FDA Product Code

EJFBRACKET, METAL, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-10
Device Publish Date2019-05-02

On-Brand Devices [Direct Bond Eyelets]

00190730011718Round Direct Bond Eyelet 10 per pack
00190730088277Rectangle Direct Bond Eyelet 10 per pack

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