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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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DBX Mix, 20cc
Musculoskeletal Transplant Foundation, Inc.
058200
In Commercial Distribution

  • W4184058200T0474 ()

  • 20 cc volume
058200

  • Bone matrix implant, human-derived
The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.
NEOCOIL, LLC
20
In Commercial Distribution

  • 00856181003206 ()


  • Headphones
The AMSCO 400 Series Prevacuum Steam Sterilizers are designed for sterilization of materials used in healthcare facilities. The AMSCO 400 Series Prevacuum Steam Sterilizers are equipped with Prevacuum, gravity, leak test, and daily air removal test cycles and offers optional Steam Flush Pressure Pulse (SFPP) configuration.
Steris Mexico, S. de R.L. de C.V.
20
In Commercial Distribution

  • 00724995151652 ()
SR02

  • Steam sterilizer
The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to a qualified laboratory for testing.
Home Access Health Corporation
20
In Commercial Distribution

  • M769HIVEXPRESS201 ()


  • Capillary blood collection set, home-use
No Description
Roland Consult Stasche & Finger GmbH
20
In Commercial Distribution

  • 04260157780200 ()


  • Electroretinograph
  • Electrooculograph
No Description
ELITechGroup B.V.
20
Not in Commercial Distribution

  • 03661540700125 ()


  • Erthrocyte sedimentation rate (ESR) analyser IVD
No Description
ELITechGroup B.V.
20
Not in Commercial Distribution

  • 03661540700118 ()


  • Erthrocyte sedimentation rate (ESR) analyser IVD
Plan-a-pregnancy kit with Natural Cycles 6 month subscription, a basal thermometer, 10 ovulation strip tests and 5 pregnancy strip tests.
Naturalcycles Nordic AB
20
In Commercial Distribution

  • 07350014630209 ()


  • Self-care monitoring/reporting software
  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Nyström, one pair, I and II
E. Hahnenkratt GmbH
20
In Commercial Distribution

  • E206200 ()


  • Dental matrix band tensioner
The Anovo Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic procedures. The system comprises Anovo Surgeon Console, two sterile instruments (Instrument ARMS), Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Pedestal and Vaginal Access Kit). The Robotic Control Unit includes two Robotic Control Units permanently attached to each other by Momentis Surgical (cannot be separated by user). Robotic Control Unit contains brushed motors, sensors, drivers, and the electronic board required to drive the Instrument ARMS. Each Robotic Control Unit drives one Arm. The Robotic Control Unit is mounted on the Pedestal.
MOMENTIS SURGICAL LTD
20
In Commercial Distribution

  • 17290018151324 ()
  • 07290018151310 ()
FP-02-0003

  • Endoscopic electromechanical surgical system
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