Micro C Load Bearing Cassette Plate, ACSY-S009

Basic Information

• Brand Name: Micro C Load Bearing Cassette Plate, ACSY-S009
• Primary DI: 00860008892751
• Version / Model: ACSY-S009
• Company Name: Oxos Medical, Inc.
• Labeler DUNS: 080323883
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-19
• Public Version: 1
• Public Version Date: 2022-10-27
• Public Version Status: New
• Public Device Record Key: ccb7f4de-08c6-4f7e-8170-0d354e0f20af

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
IZL	System, X-Ray, Mobile	Radiology	892.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64687	Flat panel x-ray detector/film cassette weight-bearing protector	A device intended to cover a flat panel x-ray detector or film cassette (neither included) on which a patient stands, to protect the cassette/detector from the patient’s body weight during a computed or digital radiography procedure of the feet. It is made of radiolucent materials with low x-ray attenuation/scattering. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860008892751	GS1

Premarket Submissions

Submission Number	Supplement Number
K212654	000