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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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
AGIROMC1-1(DD)
In Commercial Distribution

  • 00850015518041 ()
  • 00850015518010 ()
  • 00850015518119 ()
AGIROMC1-1(DD)

  • Gastrointestinal telemetric monitoring system capsule, ingestible
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
AGIROMC1-1(R)
In Commercial Distribution

  • 00850015518034 ()
  • 00850015518003 ()
  • 00850015518089 ()
AGIROMC1-1(R)

  • Gastrointestinal telemetric monitoring system capsule, ingestible
ONO PETTER, 1000/box
KOVA INTERNATIONAL, INC.
4249
In Commercial Distribution

  • 00850015517105 ()
4249

  • User-induced pipette
KOVA-poc, Urinalysis System Pac
KOVA INTERNATIONAL, INC.
88100
In Commercial Distribution

  • 00850015517075 ()
88100

  • Centrifuge tube IVD
  • User-induced pipette
  • General specimen microscopy slide IVD, single-use
Headless Compression System 2.0mm Hex Driver Shaft Cannulated
Osteocentric Technologies, Inc.
EX01-0033
In Commercial Distribution

  • 00850015496394 ()
EX01-0033

  • Surgical screwdriver, reusable
Headless Compression System 1.5mm Hex Driver Shaft Cannulated
Osteocentric Technologies, Inc.
EX01-0032
In Commercial Distribution

  • 00850015496387 ()
EX01-0032

  • Surgical screwdriver, reusable
Headless Compression System 2.9mm Drill Bit Cannulated
Osteocentric Technologies, Inc.
EX01-0031
In Commercial Distribution

  • 00850015496370 ()

  • Outer Diameter: 2.9 Millimeter
EX01-0031

  • Cannulated surgical drill bit, reusable
Headless Compression System 2.1mm Drill Bit Cannulated
Osteocentric Technologies, Inc.
EX01-0030
In Commercial Distribution

  • 00850015496363 ()

  • Outer Diameter: 2.1 Millimeter
EX01-0030

  • Cannulated surgical drill bit, reusable
Headless Compression System Ratcheting Handle Quick Connect
Osteocentric Technologies, Inc.
EX01-0025
In Commercial Distribution

  • 00850015496356 ()
EX01-0025

  • Orthopaedic inorganic implant inserter/extractor, reusable
Headless Compression System 6-7-8mm Parallel K-Wire Guide
Osteocentric Technologies, Inc.
EX01-0021
In Commercial Distribution

  • 00850015496349 ()
EX01-0021

  • Surgical drill guide, reusable
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