FDA.report

CAP

Primary DI
00840186696419
Brand
CAP
Company
BURLINGTON MEDICAL, LLC
Model
CAP8-R8CAP-LG_XL
Device description
Cap - Standard Size with Drawstring Toggle Closure, .5mm Xenolite 800 NL Size Small / Medium, CAP8-R8CAP-LG_XL
Published
2022-09-09
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
00840186696419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840186696419008401866964198401866964190840186696419

GMDN Terms

TermDefinition
Radiation shielding head wearA personal protective device intended to shield the head of an individual (i.e., the operator or other attending person) from unnecessary primary and scattered radiation during diagnostic or therapeutic medical procedures. It can be shaped like a cap or hood and will typically consist of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Head wear used for neutron attenuation is composed of hydrogenous materials instead of lead; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials.

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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