Micro C Load Bearing Cassette Plate, ACSY-S009

GUDID 00860008892751

Oxos Medical, Inc.

Flat panel x-ray detector/film cassette weight-bearing protector

• Primary Device ID: 00860008892751
• NIH Device Record Key: ccb7f4de-08c6-4f7e-8170-0d354e0f20af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micro C Load Bearing Cassette Plate, ACSY-S009
• Version Model Number: ACSY-S009
• Company DUNS: 080323883
• Company Name: Oxos Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008892751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212654

FDA Product Code

• IZL: System, X-Ray, Mobile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-27
• Device Publish Date: 2022-10-19

Devices Manufactured by Oxos Medical, Inc.

• 00860008892768 - Foot and Ankle Stand: 2025-06-10
• 00860001123418 - Cassette: 2025-01-09
• 00860001123425 - Emitter: 2025-01-09
• 00860008892706 - Foot Pedal: 2025-01-09
• 00860008892713 - Wired Charger: 2025-01-09
• 00860008892737 - Cart: 2025-01-09
• 00860008892744 - MC2 App: 2025-01-09
• 00860008892782 - MC2 Portable X-ray System: 2025-01-09