IntraMarX Radiopaque Markers AGIROMC1-1(DD)

GUDID 00850015518041

The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.

ANX ROBOTICA CORP

Gastrointestinal telemetric monitoring system capsule, ingested

• Primary Device ID: 00850015518041
• NIH Device Record Key: cebcd628-3206-48ab-b171-1b1de5adccb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntraMarX Radiopaque Markers
• Version Model Number: AGIROMC1-1(DD)
• Catalog Number: AGIROMC1-1(DD)
• Company DUNS: 024972857
• Company Name: ANX ROBOTICA CORP
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00850015518010 [Primary]
GS1	00850015518041 [Package]; Contains: 00850015518010; Package: Carton [12 Units]; In Commercial Distribution
GS1	00850015518119 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191087

FDA Product Code

• FFX: System, Gastrointestinal Motility (Electrical)

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: 2020-02-04
• Device Publish Date: 2020-01-27

On-Brand Devices [IntraMarX Radiopaque Markers]

• 00850015518058: The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic con
• 00850015518041: The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic con
• 00850015518034: The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic con