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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EPS RFA PACK
Cardinal Health 200, LLC
SANBCRFCH3
In Commercial Distribution

  • 50195594319470 ()
  • 10195594319472 ()
SANBCRFCH3

  • Cardiothoracic surgical procedure kit, medicated, single-use
EPS RFA PACK
Cardinal Health 200, LLC
SANBCRFCH4
In Commercial Distribution

  • 50195594334855 ()
  • 10195594334857 ()
SANBCRFCH4

  • Cardiothoracic surgical procedure kit, medicated, single-use
EPS RFA PACK
Cardinal Health 200, LLC
SANBCRFCHF
In Commercial Distribution

  • 50195594578228 ()
  • 10195594578220 ()
SANBCRFCHF

  • Cardiothoracic surgical procedure kit, medicated, single-use
UNQ EPS PACK
Cardinal Health 200, LLC
36-3956A
In Commercial Distribution

  • 50198956068559 ()
  • 10198956068551 ()
36-3956A

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
CardioPerfect Workstation Software Update (latest version)
WELCH ALLYN, INC.
901047
In Commercial Distribution

  • 00732094041033 ()
UPDT-WACPW-CD

  • Electrocardiograph, professional, multichannel
No Description
EMD Technologies
EPS
In Commercial Distribution

  • 00055846500009 ()


  • Diagnostic x-ray system generator, stationary
The Reliance EPS Processor with base is intended for washing and high Level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories.
Corporation Steris Canada
EPS
Not in Commercial Distribution

  • 00724995193706 ()
MB000081

  • Endoscope washer/disinfector
The Reliance EPS Processor with base is intended for washing and high Level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories.
Corporation Steris Canada
EPS
Not in Commercial Distribution

  • 00724995193690 ()
MB000080

  • Endoscope washer/disinfector
The Reliance EPS Processor with base is intended for washing and high Level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories.
Corporation Steris Canada
EPS
Not in Commercial Distribution

  • 00724995193683 ()
MB000079

  • Endoscope washer/disinfector
The Reliance EPS Processor with base is intended for washing and high Level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories.
Corporation Steris Canada
EPS
Not in Commercial Distribution

  • 00724995193676 ()
MB000078

  • Endoscope washer/disinfector
The Reliance EPS Processor with base is intended for washing and high Level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories.
Corporation Steris Canada
EPS
Not in Commercial Distribution

  • 00724995193669 ()
MB000077

  • Endoscope washer/disinfector
The Reliance EPS Processor is intended for washing and high Level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories.
Corporation Steris Canada
EPS
Not in Commercial Distribution

  • 00724995152178 ()
MB3

  • Endoscope washer/disinfector
PRICE MUSCLE BIOPSY CLMP
TELEFLEX INCORPORATED
IPN912395
In Commercial Distribution

  • 54026704810739 ()
  • 14026704810731 ()
P29076

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Screwdriver Machine Slot
Nobel Biocare AB
2430
In Commercial Distribution

  • 07332747023244 ()
2430

  • Surgical screwdriver, reusable
EVERCLEAN MAINTENANCE MACHINE
Peter Brasseler Holdings, LLC
5028208U0
In Commercial Distribution

  • 00887919871873 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic
Genius Anesthetic Machine
SPACELABS HEALTHCARE (WASHINGTON), INC
Genius
In Commercial Distribution

  • 10841522100048 ()
Genius

  • Anaesthesia unit, mobile
Focus Anesthetic Machine
SPACELABS HEALTHCARE (WASHINGTON), INC
Focus
In Commercial Distribution

  • 10841522100031 ()
Focus

  • Anaesthesia unit, mobile
Portable Suction Machine
SUNSET HEALTHCARE SOLUTIONS, INC.
SU100DC
In Commercial Distribution

  • 00848530088965 ()
  • 10848530088962 ()
SU100DC

  • General-purpose suction system, line-powered
Machine Screwdriver abutment
Cochlear Bone Anchored Solutions AB
90397
In Commercial Distribution

  • 09321502034579 ()
90397

  • Surgical screwdriver, reusable
Cocoon Warming Machine
CARE ESSENTIALS PTY LTD
CWS 5000
In Commercial Distribution

  • 09332017002007 ()
CWS 5000

  • Circulating-air whole-body heating system control unit
Cocoon Warming Machine
CARE ESSENTIALS PTY LTD
CWS 4000
In Commercial Distribution

  • 09332017000553 ()
CWS 4000

  • Circulating-air whole-body heating system control unit
Abutment inserter, machine
Oticon Medical AB
M51695
In Commercial Distribution

  • 05712149005895 ()
M51695

  • Surgical screwdriver, reusable
Screwdriver, machine, 35mm
Oticon Medical AB
M50384
In Commercial Distribution

  • 05712149000562 ()
M50384

  • Surgical screwdriver, reusable
Therapy Machine (Non-App)
NUVOMED, INC.
INV00564
In Commercial Distribution

  • 00859811008510 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Therapy Machine (Non-App)
NUVOMED, INC.
TTM-6/0740
In Commercial Distribution

  • 00859811007407 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Air purification machine
AEROBIOTIX, INC.
HUAIRS-MD
In Commercial Distribution

  • 00852348007995 ()


  • Surgical laminar airflow unit
Air purification machine
AEROBIOTIX, INC.
HUAIRS+
In Commercial Distribution

  • 00852348007988 ()


  • Surgical laminar airflow unit
Air purification machine
AEROBIOTIX, INC.
SENSE
In Commercial Distribution

  • 00852348007889 ()


  • Surgical laminar airflow unit
Air purification machine
AEROBIOTIX, INC.
AeroCure-MD
In Commercial Distribution

  • 00852348007773 ()


  • Surgical laminar airflow unit
Air purification machine
AEROBIOTIX, INC.
AeroCure Vac
In Commercial Distribution

  • 00852348007551 ()


  • Surgical laminar airflow unit
Air purification machine
AEROBIOTIX, INC.
AeroCure VAC+
In Commercial Distribution

  • 00852348007155 ()


  • Surgical laminar airflow unit
Roscoe Suction Machine
COMPASS HEALTH BRANDS CORP.
50004
In Commercial Distribution

  • 20092237603370 ()
  • 00092237603376 ()


  • Emergency airway clearance suction system, electric
Dialyzer reprocessing machine.
Angelini Pharma Inc.
21.1
In Commercial Distribution

  • 00898021000037 ()
MAKY21.1

  • Haemodialysis dialyser reprocessing system
Portable Suction Machine
Drive Devilbiss Healthcare
18615
Not in Commercial Distribution

  • 10822383509140 ()
  • 00822383509143 ()


  • Vacuum suction regulator/regulation set, thoracic
Plus Suction Machine
Drive Devilbiss Healthcare
18610
Not in Commercial Distribution

  • 10822383509133 ()
  • 00822383509136 ()


  • Vacuum suction regulator/regulation set, thoracic
Ice Therapy Machine
VIVE HEALTH LLC
RHB1049GRY
In Commercial Distribution

  • 10818323022251 ()
  • 00818323022254 ()


  • Circulating-fluid localized thermal/compression therapy system control unit
Vacu-Aide Suction Machine
DEVILBISS HEALTHCARE LLC
7325P-D-EXF
In Commercial Distribution

  • 00885304032571 ()
7325P-D-EXF

  • Airway suction catheter
Vacu-Aide Suction Machine
DEVILBISS HEALTHCARE LLC
7325D-D-EXF
In Commercial Distribution

  • 00885304032557 ()
7325D-D-EXF

  • Airway suction catheter
Ice Machine Therapy
VIVE HEALTH LLC
RHB1049
In Commercial Distribution

  • 10810041981537 ()
  • 00810041981530 ()


  • Cold therapy pack chilling unit
PK EPS ABLATION CB
Cardinal Health 200, LLC
SAN4JEPCBA
In Commercial Distribution

  • 50197106521852 ()
  • 10197106521854 ()
SAN4JEPCBA

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
EPS Cortical Bone Tap
WRIGHT MEDICAL TECHNOLOGY, INC.
49513311
In Commercial Distribution

  • 00840420192684 ()

  • Size: 3.5mm
49513311

  • Bone tap, reusable
EPS PERCUTANEOUS PACK ILM
Cardinal Health 200, LLC
SANCGEPIL3
In Commercial Distribution

  • 50888439729144 ()
  • 10888439729146 ()
SANCGEPIL3

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
EPS PERCUTANEOUS PACK ILM
Cardinal Health 200, LLC
SANCGEPILA
In Commercial Distribution

  • 50888439623930 ()
  • 10888439623932 ()
SANCGEPILA

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
EPS PERCUTANEOUS PACK ILM
Cardinal Health 200, LLC
SANCGEPIL1
In Commercial Distribution

  • 50888439661918 ()
  • 10888439661910 ()
SANCGEPIL1

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
EPS PERCUTANEOUS PACK ILM
Cardinal Health 200, LLC
SANCGEPIL2
In Commercial Distribution

  • 50888439683583 ()
  • 10888439683585 ()
SANCGEPIL2

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
STERILE EPS ABLATION PACK
Cardinal Health 200, LLC
SAN23EPCHB
In Commercial Distribution

  • 50885425243479 ()
  • 10885425243471 ()
SAN23EPCHB

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
STERILE EPS RFA PACK
Cardinal Health 200, LLC
SANBCRFCHB
In Commercial Distribution

  • 50887488454212 ()
  • 10887488454214 ()
SANBCRFCHB

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
EPS 20 C 24
MAQUET SAS
ARD567355912
In Commercial Distribution

  • 03700712420345 ()


  • Operating room light
EPS 10 C 24
MAQUET SAS
ARD567355911
In Commercial Distribution

  • 03700712420338 ()


  • Operating room light
EPS 20U OR V2
MAQUET SAS
ARD567355979
In Commercial Distribution

  • 03700712420321 ()


  • Operating room light
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