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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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Stretchease Powder-Free Nitrile Examination Gloves, SML Sample Pack, 150/CS
THOMAS SCIENTIFIC, LLC
1159G-SAMPLE
In Commercial Distribution

  • 10850015524414 ()
  • 00850015524417 ()
  • 00850015524721 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Stretchease Powder-Free Nitrile Examination Gloves, Size Ex-Large, 900/CS
THOMAS SCIENTIFIC, LLC
1159G07-NI
In Commercial Distribution

  • 10850015524049 ()
  • 00850015524042 ()
  • 00850015524783 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Stretchease Powder-Free Nitrile Examination Gloves, Size Large, 1000/CS
THOMAS SCIENTIFIC, LLC
1159G06-NI
In Commercial Distribution

  • 10850015524032 ()
  • 00850015524035 ()
  • 00850015524790 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
ELECTROPHYSIOLOGY PACK
MEDLINE INDUSTRIES, INC.
DYNJ60860
In Commercial Distribution

  • 10193489666397 ()
  • 40193489666398 ()
DYNJ60860

  • General surgical procedure kit, non-medicated, single-use
Stretchease Powder-Free Nitrile Examination Gloves, Size Small, 1000/CS
THOMAS SCIENTIFIC, LLC
1159G04-NI
In Commercial Distribution

  • 10850015524018 ()
  • 00850015524011 ()
  • 00850015524813 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
LAP CHOLE-LF
MEDLINE INDUSTRIES, INC.
DYNJ38774C
In Commercial Distribution

  • 10193489666373 ()
  • 40193489666374 ()
DYNJ38774C

  • General surgical procedure kit, non-medicated, single-use
Controller. The NaviCam Xpress Stomach System is a 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 within the stomach to be controlled by an operator
ANX ROBOTICA CORP
Controller/ NaviEC-2000
In Commercial Distribution

  • 00850015518294 ()
MC-US-1002

  • Video capsule endoscopy system capsule magnetic manipulation unit
TOTAL KNEE CDS
MEDLINE INDUSTRIES, INC.
CDS941313U
In Commercial Distribution

  • 10193489666359 ()
CDS941313U

  • General surgical procedure kit, medicated
No Description
ANX ROBOTICA CORP
Combo
In Commercial Distribution

  • 00850015518232 ()
  • 00850015518256 ()


  • Gastrointestinal telemetric monitoring system capsule, ingestible
SPINAL CARE LAMINECTOMY CDS
MEDLINE INDUSTRIES, INC.
CDS780204P
In Commercial Distribution

  • 10193489666335 ()
CDS780204P

  • General surgical procedure kit, medicated
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
Stomach Capsule/AKEM-11SW
In Commercial Distribution

  • 00850015518195 ()
CP-US-7006

  • Video capsule endoscopy system capsule
EYE PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ48239C
In Commercial Distribution

  • 10193489666281 ()
  • 40193489666282 ()
DYNJ48239C

  • 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
AGIROMIC2-1-TC/1
In Commercial Distribution

  • 00850015518171 ()
AGIROMIC2-1-TC/1

  • Gastrointestinal telemetric monitoring system capsule, ingestible
DR KEYS EYE PACK
MEDLINE INDUSTRIES, INC.
DYNJ48256K
In Commercial Distribution

  • 10193489666267 ()
  • 40193489666268 ()
DYNJ48256K

  • General surgical procedure kit, non-medicated, single-use
PALISADES EYE PACK
MEDLINE INDUSTRIES, INC.
LYN047EYPPG
In Commercial Distribution

  • 10193489666250 ()
LYN047EYPPG

  • General surgical procedure kit, non-medicated, single-use
BASIC TRAY
MEDLINE INDUSTRIES, INC.
DYNJRA1385
In Commercial Distribution

  • 10193489666229 ()
  • 40193489666220 ()
DYNJRA1385

  • General surgical procedure kit, non-medicated, single-use
1ST YEAR KIT
MEDLINE INDUSTRIES, INC.
EDUC1019A
In Commercial Distribution

  • 10193489666212 ()
EDUC1019A

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

  • 00850015518126 ()
AGIROMC1-1-R/1

  • Gastrointestinal telemetric monitoring system capsule, ingestible
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule; NaviCam Stomach System.
ANX ROBOTICA CORP
Locator AKS-1
In Commercial Distribution

  • 00850015518072 ()
SB-US-2006

  • Video capsule endoscopy monitoring kit
  • Video capsule endoscopy system capsule magnetic activator
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(TC)
In Commercial Distribution

  • 00850015518058 ()
  • 00850015518027 ()
  • 00850015518102 ()
AGIROMC1-1(TC)

  • 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)
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
UA Diptube Liquid QC
KOVA INTERNATIONAL, INC.
11561694
In Commercial Distribution

  • 00850015517211 ()
11561694

  • Urine sediment IVD, control
Liquid QC Kit
KOVA INTERNATIONAL, INC.
11561695
In Commercial Distribution

  • 00850015517204 ()
11561695

  • Urine sediment IVD, control
Liquid QC Kit + Sediment
KOVA INTERNATIONAL, INC.
11561696
Not in Commercial Distribution

  • 00850015517198 ()
11561696

  • Urine sediment IVD, control
Glasstic Slide 10 with Grids, 1000 determinations
KOVA INTERNATIONAL, INC.
87144F
In Commercial Distribution

  • 00850015517181 ()
87144F

  • General specimen microscopy slide IVD, single-use
Premium Liquid urine diptube style with micro- 15mL
KOVA INTERNATIONAL, INC.
89228
In Commercial Distribution

  • 00850015517167 ()
89228

  • Urine sediment IVD, control
KOVA TROL III (4 x 15mL)
KOVA INTERNATIONAL, INC.
4265
In Commercial Distribution

  • 00850015517150 ()
4265

  • Urine sediment IVD, control
KOVA TROL I (4 x 15mL)
KOVA INTERNATIONAL, INC.
4263
In Commercial Distribution

  • 00850015517143 ()
4263

  • Urine sediment IVD, control
KOVA TROL II (4 x 15mL)
KOVA INTERNATIONAL, INC.
4255
In Commercial Distribution

  • 00850015517136 ()
4255

  • Urine sediment IVD, control
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