FDA.report

Coat Apron, Lead .5mm 24 X 42

Primary DI
00843696124229
Brand
Coat Apron, Lead .5mm 24 X 42
Company
FLOW X RAY CORPORATION
Model
63011-23
Device description
Coat Apron, Lead .5mm Large 24 X 42, Beige
Published
2020-03-20
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
00843696124229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00843696124229008436961242298436961242290843696124229

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
010016319
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
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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