ScatPad

Basic Information

• Brand Name: ScatPad
• Primary DI: 00814907020654
• Version / Model: SEPA 463-X-AF
• Catalog Number: SEPA 463-X-AF
• Company Name: CARDIO-MEDICAL PRODUCTS, INC.
• Labeler DUNS: 029286150
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-12
• Public Version: 1
• Public Version Date: 2024-09-20
• Public Version Status: New
• Public Device Record Key: 2cdf67ff-afe3-4377-bbc2-03e93a453ff2

Device Description

SCATPAD SEPA 463-X-AFCath/EP Multi-Purpose Extra Large Specialty Shield, Attenuation @90k Vp > 95% (0.375mm), Scatter Radiation Drape, Absorbent, Airtex Fabric, Scoop and Adjustable Fenestration Tri Level, Tape

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IWX	Barrier, Control Panel, X-Ray, Movable	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38373	Radiation shielding panel, portable/mobile	A 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].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10814907020651	GS1	Box	10	In Commercial Distribution
Primary	00814907020654	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 40 – 104 Degrees Fahrenheit