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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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The HLT Foot Section is used with 3085 Surgical Table.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995163983 ()
BF393

  • Multifunction body cushion
EndoGator Tubing Hybrid, Olympus is used with EndoGator Irrigation Pump
MEDIVATORS INC.
4003168
In Commercial Distribution

  • 10724995224117 ()
  • 00724995224110 ()
  • 50724995224115 ()
4003168

  • Surgical irrigation tubing set, single-use
ALYON Single Light is used with the ALYON Lighting System
STERIS CORPORATION
ALYON Surgical Lighting System
In Commercial Distribution

  • 00724995222987 ()
LYS01

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
ALYON Non-camera Lighthead is used with the ALYON Lighting System
STERIS CORPORATION
ALYON Surgical Lighting System
In Commercial Distribution

  • 00724995222963 ()
LYS00019

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
OrLocate HoveRead is used with th ORLocate Sponge Solution System.
Steris Corporation
ORLocate HoveRead
Not in Commercial Distribution

OX201

  • Radiopaque woven surgical sponge
OrLocate Locator is used with the ORLocate Sponge Solution System.
Steris Corporation
ORLocate Locator
Not in Commercial Distribution

OX202

  • Radiopaque woven surgical sponge
The 2-inch - IA Board Pad is used with surgical tables.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995182304 ()
BF828

  • Operating table mattress, basic
Catheter extension is used with the CMAX X-Ray Imaging Table
STERIS
TAB800KT
Not in Commercial Distribution

  • 00724995178260 ()
BF789

  • Surgical instrument interim-placement holder, reusable
The 1-inch TLT Armboard Pad is used with surgical tables.
STERIS CORPORATION
Armboard Pad
In Commercial Distribution

  • 00724995216535 ()
BF345

  • Operating table mattress, basic
Transmitter which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
BWI-D
In Commercial Distribution

  • 00864037000378 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
Receiver which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
T-Link Receiver
In Commercial Distribution

  • 00864037000323 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
Transmitter which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
TM8B Transmitter
In Commercial Distribution

  • 00864037000316 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
Transmitter which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
TM8D Transmitter
In Commercial Distribution

  • 00864037000309 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
oneNEST S 80''x 35'' is a non-powered foam surface
Umano Medical Inc
303-803508HS4FB-BIL
In Commercial Distribution

  • 00670482000708 ()
  • 10670482000705 ()
303-803508HS4FB-BIL

  • Foam bed mattress
oneNEST S 84" x 35'' is a non-powered foam surface
Umano Medical Inc
303-843508HS4FB-BIL
In Commercial Distribution

  • 00670482000692 ()
  • 10670482000699 ()
303-843508HS4FB-BIL

  • Foam bed mattress
It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64523-TRI
In Commercial Distribution

  • 10670482000583 ()
  • 00670482000586 ()
FA64523-TRI

  • Freestanding/bed-attached intravenous pole
It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64506-TRI
In Commercial Distribution

  • 10670482000538 ()
  • 00670482000531 ()
FA64506-TRI

  • Freestanding/bed-attached intravenous pole
It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64521-TRI
In Commercial Distribution

  • 10670482000576 ()
  • 00670482000579 ()
FA64521-TRI

  • Freestanding/bed-attached intravenous pole
It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64507-TRI
In Commercial Distribution

  • 10670482000569 ()
  • 00670482000562 ()
FA64507-TRI

  • Freestanding/bed-attached intravenous pole
It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64508-TRI
In Commercial Distribution

  • 10670482000545 ()
  • 00670482000548 ()
FA64508-TRI

  • Freestanding/bed-attached intravenous pole
This is the Metabolic Solutions Kit version of the kit.
Otsuka America Pharmaceutical Inc
01M
In Commercial Distribution

  • 00857335005039 ()
  • 10857335005043 ()


  • Helicobacter pylori urease IVD, kit, chromogenic
Is a digital device used to measure blood pressure (Upper-arm)
SILEX GLOBAL LLC
Digital Blood Pressure Monitor (Upper-arm) B22S
In Commercial Distribution

  • 00856324008730 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Is a digital device used to measure blood pressure (Upper-arm)
SILEX GLOBAL LLC
Digital Blood Pressure Monitor (Upper-arm) B15
In Commercial Distribution

  • 00856324008723 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Is a digital device used to measure blood pressure (Upper-arm)
SILEX GLOBAL LLC
Digital Blood Pressure Monitor (Upper-arm) B22
In Commercial Distribution

  • 00856324008693 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Is a digital device used to measure blood pressure Upper-arm)
SILEX GLOBAL LLC
Digital Blood Pressure Monitor (Upper-arm) B22
In Commercial Distribution

  • 00856324008099 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.
Lina Medical ApS
OP-LAS16-3
In Commercial Distribution

  • 05708265011896 ()
  • 05708265011889 ()
OP-LAS16-3

  • Mechanical-cutting endoscopic polypectomy snare
LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.
Lina Medical ApS
OP-LAS16-3
Not in Commercial Distribution

  • 05708265011537 ()
  • 05708265011544 ()
OP-LAS16-3

  • Mechanical-cutting endoscopic polypectomy snare
The identifeye Camera System is a fundus ophthalmic camera reconditioned.
Identifeye Health Inc.
850-30004-00
In Commercial Distribution

  • 00850067214281 ()


  • Ophthalmic fundus camera
ClearCheck is intended for quality assessment of radiotherapy treatment plans.
Radformation, Inc
2.0
In Commercial Distribution

  • 00860001672701 ()


  • Radiation therapy software
The Femur Hook, Angled 58-degree is used with orthopedic procedures.
STERIS CORPORATION
Femur Hook
In Commercial Distribution

  • 00724995194017 ()
BF677

  • Bone hook
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