FDA.report

Patient Apron

Primary DI
G031300NL0
Brand
Patient Apron
Company
Shielding International Inc.
Model
300NL
Device description
Patient Apron Adult - 0.25mm Non Lead NL Width 23" (58.4cm) Length 26" (66cm)
Published
2023-08-07
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
IWOApron, Protective

Product Code Classifications

CodeDeviceSpecialtyClass
IWOApron, ProtectiveRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G031300NL0PrimaryHIBCC0

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
009647322
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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G031WABRX2XFTLL0Wrap Around Back Relief Apron - BRX BeltWABRX2XFTLL2023-10-17
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G031WABRX2XMLFL0Wrap Around Back Relief Apron - BRX BeltWABRX2XMLFL2023-10-17
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G031WABRX2XMNLL0Wrap Around Back Relief Apron - BRX BeltWABRX2XMNLL2023-10-17
G031WABRX2XMRL0Wrap Around Back Relief Apron - BRX BeltWABRX2XMRL2023-10-17
G031WABRX2XMRLL0Wrap Around Back Relief Apron - BRX BeltWABRX2XMRLL2023-10-17
G031WABRX2XMTL0Wrap Around Back Relief Apron - BRX BeltWABRX2XMTL2023-10-17
G031WABRX2XMTLL0Wrap Around Back Relief Apron - BRX BeltWABRX2XMTLL2023-10-17
G031WABRXMFLF0Wrap Around Back Relief Apron - BRX BeltWABRXMFLF2023-10-17
G031WABRXMFLFL0Wrap Around Back Relief Apron - BRX BeltWABRXMFLFL2023-10-17
G031WABRXMFNL0Wrap Around Back Relief Apron - BRX BeltWABRXMFNL2023-10-17
G031WABRXMFNLL0Wrap Around Back Relief Apron - BRX BeltWABRXMFNLL2023-10-17

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