Angiosystems inc

Basic Information

• Brand Name: Angiosystems inc
• Primary DI: 00816611025925
• Version / Model: sx8200 case
• Company Name: ANGIOSYSTEMS, INCORPORATED
• Labeler DUNS: 144884467
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-25
• Public Version: 1
• Public Version Date: 2024-10-03
• Public Version Status: New
• Public Device Record Key: 08fa6a6b-e067-41f1-bf9b-f894fbab7bc4

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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
KPY	Shield, Protective, Personnel	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64601	Radiation shielding table drape	A protective device intended to be placed on/draped over part of an operating table for a radiological examination during a surgical procedure (e.g. fluoroscopy using a C-arm) to shield attending healthcare personnel 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 which may in part be segmented into strips to allow passage of equipment under the table. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816611025925	GS1