Bondable Space Maintainer 855-320

GUDID 00190746074981

SPACE MAINTAINER KIT OF 16

AMERICAN ORTHODONTICS CORPORATION

Orthodontic space maintainer Orthodontic space maintainer Orthodontic space maintainer Orthodontic space maintainer Orthodontic space maintainer Orthodontic space maintainer Orthodontic space maintainer Orthodontic space maintainer Orthodontic space maintainer Orthodontic space maintainer Orthodontic space maintainer Orthodontic space maintainer Orthodontic space maintainer Orthodontic space maintainer
Primary Device ID00190746074981
NIH Device Record Keyb40bc03e-aeea-4fd5-8f04-75a989e04c4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBondable Space Maintainer
Version Model Number855-320
Catalog Number855-320
Company DUNS044668515
Company NameAMERICAN ORTHODONTICS CORPORATION
Device Count1
DM Exemptfalse
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746074981 [Primary]
GS100190746074981 [Primary]
GS100190746074981 [Primary]
GS100190746074981 [Primary]
GS100190746074981 [Primary]
GS100190746074981 [Primary]
GS100190746074981 [Primary]
GS100190746074981 [Primary]
GS100190746074981 [Primary]
GS100190746074981 [Primary]
GS100190746074981 [Primary]
GS100190746074981 [Primary]
GS100190746074981 [Primary]
GS100190746074981 [Primary]

FDA Product Code

DYTMAINTAINER, SPACE PREFORMED, ORTHODONTIC
DYTMAINTAINER, SPACE PREFORMED, ORTHODONTIC
DYTMAINTAINER, SPACE PREFORMED, ORTHODONTIC
DYTMAINTAINER, SPACE PREFORMED, ORTHODONTIC
DYTMAINTAINER, SPACE PREFORMED, ORTHODONTIC
DYTMAINTAINER, SPACE PREFORMED, ORTHODONTIC
DYTMAINTAINER, SPACE PREFORMED, ORTHODONTIC
DYTMAINTAINER, SPACE PREFORMED, ORTHODONTIC
DYTMAINTAINER, SPACE PREFORMED, ORTHODONTIC
DYTMAINTAINER, SPACE PREFORMED, ORTHODONTIC
DYTMAINTAINER, SPACE PREFORMED, ORTHODONTIC
DYTMAINTAINER, SPACE PREFORMED, ORTHODONTIC
DYTMAINTAINER, SPACE PREFORMED, ORTHODONTIC
DYTMAINTAINER, SPACE PREFORMED, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-04

Devices Manufactured by AMERICAN ORTHODONTICS CORPORATION

00190746163142 - Metal Custom Rx2020-10-01 WELDABLE BRACKET NARROW TWIN V-SLOT 022 TQ=0 A=0 R=0 PROFILE=065 M/D=100
00190746134661 - General Instruments2020-09-17 INSTRUMENT LIGATURE DIRECTOR
00190746134692 - General Instruments2020-09-17 INSTRUMENT DONTRIX GAUGE 16 OUNCE
00190746134708 - General Instruments2020-09-17 INSTRUMENT DISTAL TWISTER SMALL
00190746134715 - General Instruments2020-09-17 INSTRUMENT DISTAL TWISTER LARGE
00190746134722 - General Instruments2020-09-17 INSTRUMENT SINGLE END EXPLORER STAINLESS STEEL SPRING WIRE TIP
00190746162497 - Wildlife2020-09-17 BULK LATEX ELASTICS - GENERAL PURPOSE 2.5 OZ. 1/4"
00190746162503 - Wildlife2020-09-17 BULK LATEX ELASTICS - GENERAL PURPOSE 6.5 OZ. 1/4"

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