Home GUDID D0038618047011 SOOTHE-GUARD AIR®
Primary DI D0038618047011
Brand SOOTHE-GUARD AIR®
Company Dentsply International Inc.
Model 861804701
Catalog number 861804701
Device description Soothe-Guard Air® Child Apron with Collar .35mm - Navy Blue
Published 2022-11-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name IWO Apron, protective
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IWO Apron, Protective Radiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D0038618047011 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Radiation shielding apron A full or half-length apron-like garment intended to shield portions of the body of an individual (i.e., a device operator, patient, or other attending person) from exposure to radiation during medical or dental procedures. Some include attached or detachable collars for neck and thyroid protection. The device typically consists of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Those used for neutron attenuation are composed of hydrogenous materials; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Hang or store flat Special Storage Condition, Specify 0 0 Models with magnetic closure have potential magnetic interference with pacemakers, defibrillators, and other active implanted devices.
Regulatory Flags# DUNS number 795572718 Device count 1 Premarket exempt true Lot or batch true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D0026243451 Enhance® mini Finishing System 624345 624345 2022-04-11 D0026243551 Enhance® mini Finishing System 624355 624355 2022-04-11 D0026243651 Enhance® mini Finishing System 624365 624365 2022-04-11 D0026243751 Enhance® mini Finishing System 624375 624375 2022-10-13 D0026243851 Enhance® mini Finishing System 624385 624385 2022-04-11 D002624550001 Polytrays 62455000 62455000 2022-07-07 D002624550011 Polytrays 62455001 62455001 2022-07-07 D002624550021 Polytrays 62455002 62455002 2022-07-07 D002624551001 Polytrays 62455100 62455100 2022-07-07 D002624551011 Polytrays 62455101 62455101 2022-07-07 D002624551021 Polytrays 62455102 62455102 2022-07-07 D002624551031 Polytrays 62455103 62455103 2022-07-07 D002624551051 Polytrays 62455105 62455105 2022-07-07 D0026076071 Calibra® Bio Bioceramic Luting Cement 607607 607607 2022-04-20 D0026590301 Palodent® Sectional Matrix System 659030 659030 2019-04-02 D0026590701 Palodent® Sectional Matrix System 659070 659070 2019-04-02 D0026631001 AutoMate® 663100 663100 2019-04-02 D0013010121 Ceramco® 3 Powder Opaque i2/i4 301012 2016-09-21 D0013010211 Ceramco® 3 Powder Opaque D2 301021 2016-09-21 D0013010311 Ceramco® 3 Powder Opaque Modifier Yellow 301031 2016-09-21
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