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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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CRANI PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ47942B
In Commercial Distribution

  • 10193489666298 ()
  • 40193489666299 ()
DYNJ47942B

  • General surgical procedure kit, non-medicated, single-use
DATA RECORDER. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule to be controlled by an operator.
ANX ROBOTICA CORP
Recorder/AKR-1
In Commercial Distribution

  • 00850015518188 ()
MC-US-1006

  • Video capsule endoscopy monitoring kit
  • Video capsule endoscopy system monitor
NC3G SLEEVE PACK
MEDLINE INDUSTRIES, INC.
DYNJ58481A
In Commercial Distribution

  • 10193489666274 ()
DYNJ58481A

  • General surgical procedure kit, non-medicated, single-use
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
AGIROMC2-1-O/1
In Commercial Distribution

  • 00850015518164 ()
AGIROMC2-1-O/1

  • Gastrointestinal telemetric monitoring system capsule, ingestible
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
AGIROMC2-1-D/1
In Commercial Distribution

  • 00850015518157 ()
AGIROMC2-1-D/1

  • 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
AGIROMC-1-TC/1
In Commercial Distribution

  • 00850015518140 ()
AGIROMC-1-TC/1

  • 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-DD/1
In Commercial Distribution

  • 00850015518133 ()
AGIROMC1-1-DD/1

  • Gastrointestinal telemetric monitoring system capsule, ingestible
PERI GYN (GMHK )180
MEDLINE INDUSTRIES, INC.
DYNJ900053A
In Commercial Distribution

  • 10193489666205 ()
  • 40193489666206 ()
DYNJ900053A

  • General surgical procedure kit, non-medicated, single-use
BANGOR SURGERY TURNOVER
MEDLINE INDUSTRIES, INC.
DYKC1446
In Commercial Distribution

  • 40193489666190 ()
  • 10193489666199 ()
DYKC1446

  • General surgical procedure kit, non-medicated, single-use
CYSTO PACK
MEDLINE INDUSTRIES, INC.
DYNJ43231A
In Commercial Distribution

  • 10193489666182 ()
  • 40193489666183 ()
DYNJ43231A

  • General surgical procedure kit, non-medicated, single-use
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