IntraMarX 3D

GUDID 00850015518232

ANX ROBOTICA CORP

Gastrointestinal telemetric monitoring system capsule, ingested Gastrointestinal telemetric monitoring system capsule, ingested Gastrointestinal telemetric monitoring system capsule, ingested Gastrointestinal telemetric monitoring system capsule, ingested Gastrointestinal telemetric monitoring system capsule, ingested Gastrointestinal telemetric monitoring system capsule, ingested Gastrointestinal telemetric monitoring system capsule, ingested Gastrointestinal telemetric monitoring system capsule, ingested Gastrointestinal telemetric monitoring system capsule, ingested Gastrointestinal telemetric monitoring system capsule, ingested Gastrointestinal telemetric monitoring system capsule, ingested Gastrointestinal telemetric monitoring system capsule, ingested Gastrointestinal telemetric monitoring system capsule, ingested Gastrointestinal telemetric monitoring system capsule, ingested Gastrointestinal telemetric monitoring system capsule, ingestible Gastrointestinal telemetric monitoring system capsule, ingestible Gastrointestinal telemetric monitoring system capsule, ingestible Gastrointestinal telemetric monitoring system capsule, ingestible Gastrointestinal telemetric monitoring system capsule, ingestible Gastrointestinal telemetric monitoring system capsule, ingestible Gastrointestinal telemetric monitoring system capsule, ingestible Gastrointestinal telemetric monitoring system capsule, ingestible Gastrointestinal telemetric monitoring system capsule, ingestible Gastrointestinal telemetric monitoring system capsule, ingestible Gastrointestinal telemetric monitoring system capsule, ingestible

• Primary Device ID: 00850015518232
• NIH Device Record Key: 2789d80d-0996-433c-808d-a5cef929eb0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntraMarX 3D
• Version Model Number: Combo
• Company DUNS: 024972857
• Company Name: ANX ROBOTICA CORP
• Device Count: 1
• 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	00850015518232 [Primary]
GS1	00850015518256 [Package]; Package: box [10 Units]; Discontinued: 2020-12-08; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201106

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: 2020-12-16
• Device Publish Date: 2020-12-08

On-Brand Devices [IntraMarX 3D]

• 00850015518171: The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI conditions, includi
• 00850015518164: The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI conditions, includi
• 00850015518157: The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI conditions, includi
• 00850015518232: Combo