FDA.reportPublic FDA data

ScatPad

Primary DI
10814907020422
Brand
ScatPad
Company
CARDIO-MEDICAL PRODUCTS, INC.
Model
SAFA 301
Catalog number
SAFA 301
Device description
SCATPAD SAFA 301 Angiography Shield, Attenuation @90k Vp > 75% (0.125mm), Scatter Radiation Drape, Absorbent, Circular Fenestration Single Level
Published
2024-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IWXBarrier, Control Panel, X-Ray, Movable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWXBarrier, Control Panel, X-Ray, MovableRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814907020422PackageGS110In Commercial Distribution
00814907020425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081490702042210814907020422
00814907020425008149070204258149070204250814907020425

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding panel, portable/mobileA portable or mobile rigid barrier designed to shield patients and healthcare professionals from unnecessary exposure to radiation used in diagnostic or therapeutic medical procedures. It provides a physical radiation-attenuating barrier between an individual and a source of primary or scattered radiation. It may be a stand-alone device or intended to be integrated within an electronic system; the panel itself is not electronic. The types of materials used depend on the type of radiation to be attenuated [e.g., those used in diagnostic x-ray and nuclear medicine consist of lead (Pb) or lead-equivalent materials, and those used to attenuate neutrons are composed of hydrogenous materials].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature40 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
973-586-9500info@cardiomedicalproducts.com

Regulatory Flags#

DUNS number
029286150
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814907020029Cardio ClearLTA202LTA2022015-07-28
00814907020036Cardio ClearLOCA502LOCA5022015-07-28
00814907020050Cardio ClearH104H1042015-07-28
00814907020067Cardio ClearP403P4032015-07-28
00814907020074Cardio ClearA402A4022015-07-28
00814907020081Cardio ClearTH204TH2042015-07-28
00814907020098Cardio ClearLTH204LTH2042015-07-28
00814907020104Cardio ClearLTZ200LTZ2002015-07-28
00814907020111Cardio ClearLOCH504LOCH5042015-07-28
00814907020135Cardio ClearO101O1012015-07-28
00814907020142Cardio ClearO101-SO101-S2015-07-28
00814907020159Cardio ClearO401O4012015-07-28
00814907020166Cardio ClearTO201TO2012015-07-28
00814907020173Cardio ClearLTO201LTO2012015-07-28
00814907020180Cardio ClearLOCO501LOCO5012015-07-28
00814907020203Cardio ClearP103P1032015-07-28
00814907020210Cardio ClearH404H4042015-07-28
00814907020227Cardio ClearTP203TP2032015-07-28
00814907020234Cardio ClearLTP203LTP2032015-07-28
00814907020241Cardio ClearLOCP503LOCP5032015-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814907020548ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-14
00814907020340ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020562ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020579ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020593ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020609ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020623ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020647ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020654ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020661ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020425ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020432ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020463ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020500ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020555ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
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