FDA.report

Child Panoramic Apron .3mm 24" X 27"

Primary DI
00812045039613
Brand
Child Panoramic Apron .3mm 24" X 27"
Company
FLOW X RAY CORPORATION
Model
75062-16
Device description
Child Panoramic Lead Apron .3mm 24" X 27" Medium Blue
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
00812045039613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812045039613008120450396138120450396130812045039613

GMDN Terms

TermDefinition
Patient radiation shielding pad/drape, reusableA protective device intended to be placed on/draped over part of a patient body (typically torso or chest) during a diagnostic or therapeutic radiological procedure, to shield specific patient anatomies from unnecessary exposure to radiation. It commonly consists of a fluid-resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material; it is not a piece of clothing such as an apron. 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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