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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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OC-Auto - 00816917023304

Personal Use Kit OC-Auto, Custom Kit for Memorial Health IL
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-MEMHS
In Commercial Distribution

  • 00816917023304 ()


  • Faecal occult blood IVD, reagent

CARDINAL HEALTH - 10888439430707

LTD BODY SSP
Cardinal Health 200, LLC
SAN31LBC10
In Commercial Distribution

  • 50888439430705 ()
  • 10888439430707 ()
SAN31LBC10

  • Angiography kit

CARDINAL HEALTH - 10888439279719

LTD BODY SSP
Cardinal Health 200, LLC
SAN31LBCM9
In Commercial Distribution

  • 50888439279717 ()
  • 10888439279719 ()
SAN31LBCM9

  • Angiography kit

CARDINAL HEALTH - 10888439144413

LTD BODY SSP
Cardinal Health 200, LLC
SAN31LBCM8
In Commercial Distribution

  • 50888439144411 ()
  • 10888439144413 ()
SAN31LBCM8

  • Angiography kit

CARDINAL HEALTH - 10888439103328

LTD BODY SSP
Cardinal Health 200, LLC
SAN31LBCM7
In Commercial Distribution

  • 50888439103326 ()
  • 10888439103328 ()
SAN31LBCM7

  • Angiography kit

CARDINAL HEALTH - 10888439818444

LTD BODY SSP
Cardinal Health 200, LLC
SAN31LBC12
In Commercial Distribution

  • 50888439818442 ()
  • 10888439818444 ()
SAN31LBC12

  • Angiography kit

TytoCare Pulse Oximeter - 06945040105251

TytoCare Pulse Oximeter (IL)
Contec Medical Systems Co., Ltd.
CMS50DA+
In Commercial Distribution

  • 06945040105251 ()


  • Pulse oximeter

ambIT - 00857595005824

PIB*IL
SUMMIT MEDICAL PRODUCTS, INC.
220527
In Commercial Distribution

  • 00857595005824 ()
220527

  • Ambulatory non-insulin infusion pump, electronic

Medline Industries, Inc. - 10889942276585

IL TRAY
MEDLINE INDUSTRIES, INC.
DYNJRA0794
In Commercial Distribution

  • 10889942276585 ()
DYNJRA0794

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942849383

IL TRAY
MEDLINE INDUSTRIES, INC.
DYNJRA0794A
In Commercial Distribution

  • 10889942849383 ()
DYNJRA0794A

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

Medline Industries, Inc. - 10193489704112

IL TRAY
MEDLINE INDUSTRIES, INC.
DYNJRA1421
In Commercial Distribution

  • 10193489704112 ()
DYNJRA1421

  • General surgical procedure kit, medicated

Medline Industries, Inc. - 10193489790238

IL TRAY
MEDLINE INDUSTRIES, INC.
DYNJRA1421A
In Commercial Distribution

  • 10193489790238 ()
  • 40193489790239 ()
DYNJRA1421A

  • General surgical procedure kit, medicated

MEDLINE - 10193489190731

TPN / IL
CENTURION MEDICAL PRODUCTS CORPORATION
LC420
In Commercial Distribution

  • 20193489190738 ()
  • 10193489190731 ()
LC420

  • General surgical procedure kit, medicated

SELF THREAD/LOGIC PLUS/SPARK - 07290110727376

IMPLANT ANALOG
HI-TEC IMPLANTS LTD.
IL
In Commercial Distribution

  • 07290110727376 ()
IL

  • Dental implant analog

CARDINAL HEALTH - 10888439033441

STERILE LTD BODY SSP PACK
Cardinal Health 200, LLC
SAN31LBCM6
In Commercial Distribution

  • 50888439033449 ()
  • 10888439033441 ()
SAN31LBCM6

  • Angiography kit

CARDINAL HEALTH - 10887488229089

STERILE LTD BODY SSP PACK
Cardinal Health 200, LLC
SAN31LBCMX
In Commercial Distribution

  • 50887488229087 ()
  • 10887488229089 ()
SAN31LBCMX

  • Angiography kit

CARDINAL HEALTH - 10887488849768

STERILE LTD BODY SSP PACK
Cardinal Health 200, LLC
SAN31LBCMY
In Commercial Distribution

  • 50887488849766 ()
  • 10887488849768 ()
SAN31LBCMY

  • Angiography kit

CARDINAL HEALTH - 10887488960470

HYSTEROSCOPY FOR WOMEN LTD PK
Cardinal Health 200, LLC
SMACGHYFWC
In Commercial Distribution

  • 50887488960478 ()
  • 10887488960470 ()
SMACGHYFWC

  • Obstetrical/gynaecological surgical procedure kit, medicated

CARDINAL HEALTH - 10887488905242

HYSTEROSCOPY FOR WOMEN LTD PK
Cardinal Health 200, LLC
SMACGHYFWB
In Commercial Distribution

  • 50887488905240 ()
  • 10887488905242 ()
SMACGHYFWB

  • Obstetrical/gynaecological surgical procedure kit, medicated

VRBehavior - 07290016986167

The VRET-910 "Expose" is a prescription-only medical software used as a tool by Licensed Healthcare Provider (LHP) in order to immerse their patients into virtual reality (VR) and 360 degree simulated environments, as part of remote or in-person therapy sessions devised to improve certain mental health conditions. The software can be used in clinical settings or at home, with or without the assistance of a licensed healthcare provider.
XR HEALTH IL LTD
VRET-910 (Expose)
In Commercial Distribution

  • 07290016986167 ()


  • Hypnotherapy virtual reality software

VRCBT - 07290016986143

The AT-910 ("A10tion") is a is a virtual reality, immersive therapeutic application, indicated to train and improve cognitive function of patients with diagnosed ADHD. This application is a clinician- monitored program and should be considered for use as part of the therapeutic program that include clinician directed therapy This multidimensional training program application targets attention, executive function and memory combined with motor activation through the use of games and entertainment features.
XR HEALTH IL LTD
AT-910 (A10tion)
Not in Commercial Distribution

  • 07290016986143 ()
VRCBT AT-910

  • Mental health/function therapeutic software, screen-viewed

VRReliever - 07290016986136

The PD-810 ("Mindset") is intended to assist in relaxation and self-management of pain and physical discomfort through distraction and supporting meditation and relaxation exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The PD-810 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. The PD-810 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time.
XR HEALTH IL LTD
PD-810 (Mindset)
In Commercial Distribution

  • 07290016986136 ()
VRReliever PD-810

  • Hypnotherapy virtual reality software

VRReliever - 07290016986129

The MD-710 ("Relax8") is intended to assist in relaxation and self-management of pain and physical discomfort through distraction and supporting meditation and relaxation exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The MD-710 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. The MD-710 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time. MD-710 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
MD-710 (Relax8)
In Commercial Distribution

  • 07290016986129 ()


  • Mental health/function therapeutic software, screen-viewed
  • Hypnotherapy virtual reality software

VRCogni - 07290016986112

A software-only medical device intended to aid mitigate or assess conditions related to cognitive function by providing cognitive exercises and cognitive ability measurements. The cognitive exercises and cognitive ability measurements rely on inputs from visual and auditory stimuli, and functional use of the hands and enable guiding patients in the performance of various cognitive exercises, tracking and analyzing motion and movement kinematics and monitoring changes in patient's measurements over time.The CT-620 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. CT-620 is not intended to be used for diagnosis, treatment, decision making, or as a stand-alone device.
XR HEALTH IL LTD
CT-620 (Memorize)
In Commercial Distribution

  • 07290016986112 ()


  • Mental health/function therapeutic software, screen-viewed

VRCogni - 07290016986105

A software-only medical device intended to aid mitigate or assess conditions related to cognitive function by providing cognitive exercises and cognitive ability measurements. The cognitive exercises and cognitive ability measurements rely on inputs from visual and auditory stimuli, and functional use of the hands and enable guiding patients in the performance of various cognitive exercises, tracking and analyzing motion and movement kinematics and monitoring changes in patient's measurements over time.The CT-610 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. CT-610 is not intended to be used for diagnosis, treatment, decision making, or as a stand-alone device.
XR HEALTH IL LTD
CT-610 (Re-Act)
In Commercial Distribution

  • 07290016986105 ()


  • Mental health/function therapeutic software, screen-viewed

VRPhysio - 07290016986099

A software-only medical device intended for cervical region rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines. The N-140 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. N-140 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
N-140 (Rotate)
In Commercial Distribution

  • 07290016986099 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software

VRPhysio - 07290016986082

A software-only medical device intended for upper extremity and full body rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines. The MT-220 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. MT-220 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
MT-220 (Balloon Blast)
In Commercial Distribution

  • 07290016986082 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software

VRCogni - 07290016986075

A software-only medical device intended for motor-cognitive rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of motor-cognitive exercises according to their treating medical practitioner's guidelines. The MC-320 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. MC-320 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
MC-320 (Color Match)
In Commercial Distribution

  • 07290016986075 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software

VRReliever - 07290016986068

The CB-510 ("Luna") is intended to assist in the mitigation of pain, hot flashes and physical discomfort through distraction and supporting exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The CB-510 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. The CB-510 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time. CB-510 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
CB-510 (Luna)
In Commercial Distribution

  • 07290016986068 ()


  • Mental health/function therapeutic software, screen-viewed

VRPhysio - 07290016986044

A software-only medical device intended for upper extremity and full body conventional rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of motor-cognitive exercises according to their treating medical practitioner's guidelines.
XR HEALTH IL LTD
MC-310 (Color Match)
Not in Commercial Distribution

  • 07290016986044 ()


  • Biomechanical function analysis/rehabilitation software
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