FDA.report

SOOTHE-GUARD®

Primary DI
D0036620050001
Brand
SOOTHE-GUARD®
Company
Dentsply International Inc.
Model
662005000
Catalog number
662005000
Device description
Soothe-Guard® Adult Apron with Collar .35mm - Cool Grey
Published
2022-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EAJApron, leaded

Product Code Classifications

CodeDeviceSpecialtyClass
EAJApron, LeadedRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D0036620050001PrimaryHIBCC0

GMDN Terms

TermDefinition
Radiation shielding apronA 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

TypeLowHighCondition
Special Storage Condition, Specify00Hang or store flat
Special Storage Condition, Specify00Models with magnetic closure may have potential magnetic interference with pacemakers, defibrillators, and other active implanted devices.

Sterilization Methods

Method

Regulatory Flags

DUNS number
795572718
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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