FDA.report

PATIENTAPRON

Primary DI
00840331275360
Brand
PATIENTAPRON
Company
BURLINGTON MEDICAL, LLC
Model
RPRPA-SM
Device description
RPRPA-SM (PATIENT APRON, .5MM PRESTIGE, PATIENT APRON, 12 X 24, SM)
Published
2022-09-28
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
KPYShield, Protective, Personnel

Product Code Classifications

CodeDeviceSpecialtyClass
KPYShield, Protective, PersonnelRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840331275360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840331275360008403312753608403312753600840331275360

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
083381202
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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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