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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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Flexi-Holder W/Artic 26 Arm, (Huestis Part # FH410-GE), (GEHC Part # E6314J)
HUESTIS MACHINE CORPORATION
FH410-GE
In Commercial Distribution

  • 00850077007040 ()


  • X-ray film cassette holder
Collimator, Urology SCD, (Huestis Part # CM-1003), (GEHC part # 00-901620-01)
HUESTIS MACHINE CORPORATION
CM-1003
In Commercial Distribution

  • 00850077007033 ()


  • Automatic-aperture-control diagnostic x-ray system collimator
6693-50FGE Automatic Collimator customized for GE with spectral filters, (Huestis Part# CM-32012-008), (GEHC Part # 5220504)
HUESTIS MACHINE CORPORATION
CM-32012-008
In Commercial Distribution

  • 00850077007026 ()


  • Automatic-aperture-control diagnostic x-ray system collimator
Collimator FRU for Definium 5000, (Huestis Part # CM-3201-008), (GEHC Part # 5212898), (GE # 6693-50GE), (GE Catalog # B1100SL)
HUESTIS MACHINE CORPORATION
CM-3201-008
In Commercial Distribution

  • 00850077007019 ()


  • Automatic-aperture-control diagnostic x-ray system collimator
X-Ray Collimator, Manual
HUESTIS MACHINE CORPORATION
CM-1100
In Commercial Distribution

  • 00850077007002 ()


  • Manual-aperture-control diagnostic x-ray system collimator, non-motorized
Achilles Wedge (Large)
VIVE HEALTH LLC
SUP3070BLKL
In Commercial Distribution

  • 10810113577590 ()
  • 00810113577593 ()


  • Geometric shape exerciser
Achilles Wedge (Medium)
VIVE HEALTH LLC
SUP3070BLKM
In Commercial Distribution

  • 10810113577583 ()
  • 00810113577586 ()


  • Geometric shape exerciser
Achilles Wedge (Small)
VIVE HEALTH LLC
SUP3070BLKS
In Commercial Distribution

  • 10810113577576 ()
  • 00810113577579 ()


  • Geometric shape exerciser
Bibag Dry Sodium Bicarbonate
Fresenius Medical Care Holdings, Inc.
08-4080-BB
In Commercial Distribution

  • 10840861101327 ()
  • 00840861101320 ()
08-4080-BB

  • Haemodialysis concentrate
Bibag Dry Sodium Bicarbonate
Fresenius Medical Care Holdings, Inc.
08-4078-BB
In Commercial Distribution

  • 10840861101310 ()
  • 00840861101313 ()
08-4078-BB

  • Haemodialysis concentrate
Medfix® Adapter For Drilling Machine 1/4",Triangular End
MEDFIX INTERNATIONAL, LLC
MF750-3003
In Commercial Distribution

  • 00810021837505 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
3 SERIES MULTI MACHINE PC 311/350-24/24 208-240V 60HZ
DAAVLIN DISTRIBUTING CO., THE
3 SERIES MULTI MACHINE PC
Not in Commercial Distribution

  • B280861PH2424MMPC60 ()
861PH2424MMPC6

  • Ultraviolet phototherapy unit, professional
M SERIES MULTI MACHINE PC 311/350-4/6 110-120V 60HZ
DAAVLIN DISTRIBUTING CO., THE
M SERIES MULTI MACHINE
Not in Commercial Distribution

  • B280803MI0604MMPC60 ()
803MI0604MMPC6

  • Ultraviolet phototherapy unit, professional
M SERIES MULTI MACHINE PC 311/350-4/6 110-120V 60HZ
DAAVLIN DISTRIBUTING CO., THE
M SERIES MULTI MACHINE
Not in Commercial Distribution

  • B280801MI0604MMPC60 ()
801MI0604MMPC6

  • Ultraviolet phototherapy unit, professional
AHS Digital Blood Pressure Machine Upper Arm | Case of 24
American Hospital Supply LLC
AHSBP1_CS
In Commercial Distribution

  • 00850046814891 ()
  • 00860007667633 ()
AHSBP1_CS

  • Blood glucose/blood pressure monitoring system, home-use
Foredom powered 66" flexible shaft machine, includes Hand-held Massager Handpiece.
Foredom Electric Co
K.500L
In Commercial Distribution

  • 00098666032336 ()


  • Hand-held electric massager
Foredom powered 39" flexible shaft machine, includes Hand-held Massager Handpiece.
Foredom Electric Co
K.500
In Commercial Distribution

  • 00098666032305 ()


  • Hand-held electric massager
Hand-held Massager Handpiece used with Foredom powered flexible shaft machine.
Foredom Electric Co
H.60
In Commercial Distribution

  • 00098666028612 ()


  • Hand-held electric massager
Portable reverse osmosis machine for water purification for dialysis applications.
BETTER WATER, LLC
EQROPB1613 UL
In Commercial Distribution

  • PB0001 ()
EQROPB1613 UL

  • Combination water purification system
Tempus ECG-AF is a cardiovascular machine learning-based notification software intended to analyze recordings of 12-lead ECG devices from patients 65 years of age and older. The software employs machine learning techniques to analyze ECG recordings and detect signs associated with a patient experiencing atrial fibrillation and/or atrial flutter (collectively referred to as AF) within the next 12 months. The device is designed to extract otherwise unavailable information from ECGs conducted under the standard of care, to help health care providers better identify patients who may be at risk for undiagnosed AF in order to evaluate them for referral of further diagnostic follow up and address the unmet need of reducing the number of undiagnosed AF patients.
Tempus AI, Inc.
3
In Commercial Distribution

  • 00860011843603 ()


  • Cardiopulmonary physiological parameter analysis software
Cutting aid
Etac Supply Center AB
Cut
In Commercial Distribution

  • 07320450086670 ()
80501005

  • Food cutting/chopping aid
Knife, angled, small
Etac Supply Center AB
Relieve
In Commercial Distribution

  • 07320450002120 ()
80402102

  • Food cutting/chopping aid
Knife, angled
Etac Supply Center AB
Relieve
In Commercial Distribution

  • 07320450002113 ()
80402101

  • Food cutting/chopping aid
Cheese slicer
Etac Supply Center AB
Relieve
In Commercial Distribution

  • 07320450002373 ()
80502001

  • Food cutting/chopping aid
Carving knife, angled
Etac Supply Center AB
Relieve
In Commercial Distribution

  • 07320450002366 ()
80501101

  • Food cutting/chopping aid
Preparation board
Etac Supply Center AB
Fix
In Commercial Distribution

  • 07320450002342 ()
80501004

  • Food cutting/chopping aid
ACL TOOLBOX INSTRUMENT CASE
ARTHREX, INC.
AR-1900C
In Commercial Distribution

  • 00888867022478 ()
AR-1900C

  • Device sterilization/disinfection container, reusable
TIBIAL OSTEOTOMY TOOLBOX CASE
ARTHREX, INC.
AR-13330C2
In Commercial Distribution

  • 00888867280731 ()
AR-13330C2

  • Surgical instrument/implant rack
ACL TOOLBOX INSTRUMENT SET
ARTHREX, INC.
AR-1900S
In Commercial Distribution

  • 00888867096646 ()
AR-1900S

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Detached machine cord for P143 Bovie Model Number should be 77520-1
GRACE MANUFACTURING, INC.
27520-01
In Commercial Distribution

  • 10801334006457 ()

  • Length: 10 Feet
P143C

  • Electrical-only medical device connection cable, reprocessed
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