FDA.reportPublic FDA data

ScatPad

Primary DI
00814907020432
Brand
ScatPad
Company
CARDIO-MEDICAL PRODUCTS, INC.
Model
SAFA 302
Catalog number
SAFA 302
Device description
SCATPAD SAFA 302 Angiography Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Circular Fenestration Dual 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
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
10814907020439PackageGS110In Commercial Distribution
00814907020432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081490702043910814907020439
00814907020432008149070204328149070204320814907020432

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
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
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
05055449412650KenexKENEX (ELECTRO-MEDICAL) LIMITEDIWX2026-10-22
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
00814907020463ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020500ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020555ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00811870037788Manus Medical, LLCManus Medical, LLCIWX2023-11-08
G242LPSGS24249Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSGS24369Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSGS24489Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSH36369Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSH48489Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSS24249Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSS24369Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSS24489Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST2424S9Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST2430S9Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST2436S9Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST2448S9Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST3030S9Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST3036S9Techno-AideTechno-Aide, Inc.IWX2023-10-20