MC2 App

GUDID 00860008892744

OXOS Medical, Inc.

Hand-held basic diagnostic x-ray system, digital

• Primary Device ID: 00860008892744
• NIH Device Record Key: 21b78ec1-792b-4f1a-ba7e-db20ef307a40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MC2 App
• Version Model Number: APP
• 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: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008892744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241567

FDA Product Code

• OWB: Interventional Fluoroscopic X-Ray System

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: 2025-01-09
• Device Publish Date: 2025-01-01

Devices Manufactured by OXOS Medical, Inc.

• 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
• 00860008892744 - MC2 App: 2025-01-09
• 00860008892782 - MC2 Portable X-ray System: 2025-01-09
• 00860008892751 - Micro C Load Bearing Cassette Plate, ACSY-S009: 2022-10-27