Adult Panoramic Apron .3mm 24" X 27"

Basic Information

• Brand Name: Adult Panoramic Apron .3mm 24" X 27"
• Primary DI: 00812045039293
• Version / Model: 75061-16
• Company Name: Flow X Ray Corporation
• Labeler DUNS: 010016319
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-20
• Public Version: 3
• Public Version Date: 2023-06-28
• Public Version Status: Update
• Public Device Record Key: b854b405-ba46-42eb-adb6-9beb8c14bc3a

Device Description

Adult Panoramic Lead Apron .3mm 24" X 27" Medium Blue

Device Characteristics

• Single Use: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IWO	Apron, Protective	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64135	Patient radiation shielding pad/drape, reusable	A protective device intended to be placed on/draped over part of a patient’s body during a diagnostic or therapeutic radiological procedure to shield specific patient anatomies from unnecessary exposure to radiation and/or help block scatter radiation from the patient to protect healthcare workers.. 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812045039293	GS1