IntraMarX 3D AGIROMC2-1-O/1

GUDID 00850015518164

The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay and bowel obstruction. Each of the IntraMarX 3D 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 x-ray 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

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Primary Device ID	00850015518164
NIH Device Record Key	7befefc6-ff1a-48fa-b2bd-48f06ca2e135
Commercial Distribution Status	In Commercial Distribution
Brand Name	IntraMarX 3D
Version Model Number	AGIROMC2-1-O/1
Catalog Number	AGIROMC2-1-O/1
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	00850015518164 [Primary]

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	2020-07-16
Device Publish Date	2020-07-08

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