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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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BOSS Instruments - 00888515190481

Image-Line, micro blade, short teeth, 14x45mm, green New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6148H
In Commercial Distribution

  • 00888515190481 ()
73-6148H

  • Surgical retractor/retraction system blade, reusable

BOSS Instruments - 00888515190436

Image-Line, micro blade, short teeth, 14x40mm, red New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6147H
In Commercial Distribution

  • 00888515190436 ()
73-6147H

  • Surgical retractor/retraction system blade, reusable

BOSS Instruments - 00888515190382

Image-Line, micro blade, short teeth, 14x35mm, blue New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6146H
In Commercial Distribution

  • 00888515190382 ()
73-6146H

  • Surgical retractor/retraction system blade, reusable

BOSS Instruments - 00888515190184

Image-Line, micro blade, blunt, 14 x45mm, green New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6142H
In Commercial Distribution

  • 00888515190184 ()
73-6142H

  • Surgical retractor/retraction system blade, reusable

BOSS Instruments - 00888515190139

Image-Line, micro blade, blunt, 14 x40mm, red New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6141H
In Commercial Distribution

  • 00888515190139 ()
73-6141H

  • Surgical retractor/retraction system blade, reusable

BOSS Instruments - 00888515188310

Image-Line Blunt Blade 20mm x 75mm, Orange New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6068H
In Commercial Distribution

  • 00888515188310 ()
73-6068H

  • Surgical retractor/retraction system blade, reusable

BOSS Instruments - 00888515188273

Image-Line Blunt Blade 20mm x 65mm, Navy New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6064H
In Commercial Distribution

  • 00888515188273 ()
73-6064H

  • Surgical retractor/retraction system blade, reusable

BOSS Instruments - 00888515188259

Image-Line Blunt Blade 20mm x 60mm, Gold New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6062H
In Commercial Distribution

  • 00888515188259 ()
73-6062H

  • Surgical retractor/retraction system blade, reusable

BOSS Instruments - 00888515188235

Image-Line Blunt Blade 20mm x 55mm, Black New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6060H
In Commercial Distribution

  • 00888515188235 ()
73-6060H

  • Surgical retractor/retraction system blade, reusable

BOSS Instruments - 00888515188211

Image-Line Blunt Blade 20mm x 50mm, Violet New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6058H
In Commercial Distribution

  • 00888515188211 ()
73-6058H

  • Surgical retractor/retraction system blade, reusable

BOSS Instruments - 00888515188181

Image-Line Blunt Blade 20mm x 45mm, Green New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6056H
In Commercial Distribution

  • 00888515188181 ()
73-6056H

  • Surgical retractor/retraction system blade, reusable

BOSS Instruments - 00888515188167

Image-Line Blunt Blade 20mm x 40mm, Red New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6054H
In Commercial Distribution

  • 00888515188167 ()
73-6054H

  • Surgical retractor/retraction system blade, reusable

BOSS Instruments - 00888515188143

Image-Line Blunt Blade 20mm x 35mm, Blue New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6052H
In Commercial Distribution

  • 00888515188143 ()
73-6052H

  • Surgical retractor/retraction system blade, reusable

BOSS Instruments - 00888515188129

Image-Line Blunt Blade 20mm x 30mm, Silver New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6050H
In Commercial Distribution

  • 00888515188129 ()
73-6050H

  • Surgical retractor/retraction system blade, reusable

Single-Use Biopsy Forceps - 46932503540672

New handle, Alligator, without spike, Two Wire, 2.2*2300 mm
Micro-Tech (Nanjing) Co., Ltd.
SCNBF13-10022230
In Commercial Distribution

  • 56932503540679 ()
  • 46932503540672 ()
  • 66932503540676 ()
  • 76932503540673 ()

  • Lumen/Inner Diameter: 2.8 Millimeter
  • Length: 230 Centimeter


  • Flexible endoscopic biopsy forceps, single-use

Single-Use Biopsy Forceps - 46932503540665

New handle, Alligator, without spike, Two Wire, 2.2*1800 mm
Micro-Tech (Nanjing) Co., Ltd.
SCNBF13-10022180
In Commercial Distribution

  • 56932503540662 ()
  • 46932503540665 ()
  • 66932503540669 ()
  • 76932503540666 ()

  • Lumen/Inner Diameter: 2.8 Millimeter
  • Length: 180 Centimeter


  • Flexible endoscopic biopsy forceps, single-use

Single-Use Biopsy Forceps - 46932503540658

New handle, Alligator, with spike, Two Wire, 2.2*2300 mm
Micro-Tech (Nanjing) Co., Ltd.
SCNBF13-10122230
In Commercial Distribution

  • 56932503540655 ()
  • 46932503540658 ()
  • 66932503540652 ()
  • 76932503540659 ()

  • Lumen/Inner Diameter: 2.8 Millimeter
  • Length: 230 Centimeter


  • Flexible endoscopic biopsy forceps, single-use

ARROW - 00801902084736

Power Cord UK/Australia/New Zealand For use with IABP
TELEFLEX INCORPORATED
IPN000236
In Commercial Distribution

  • 00801902084736 ()
IAA-09695

  • Intra-aortic balloon pump

Unimed - 06945664896689

Repetitive SpO2 Probe/Photoelectric/New Finger Clip/Adult/1.1M/DB9M
Unimed Medical Supplies, Inc.
U403N-16
In Commercial Distribution

  • 06945664896689 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664896276

Blood Oxygen Cable/Spacelabs/2.2M/074+170/Nellcor/NEW Partssource
Unimed Medical Supplies, Inc.
U708-74(NPS)
In Commercial Distribution

  • 06945664896276 ()


  • Electrical-only medical device connection cable, reusable

Unimed - 06945664895804

Blood Oxygen Cable/Philips/3.0M/087+170/Nellcor/NEW Partssource
Unimed Medical Supplies, Inc.
U7M10-43(NPS)
In Commercial Distribution

  • 06945664895804 ()


  • Electrical-only medical device connection cable, reusable

Unimed - 06945664828758

Reusable SpO2 Sensor/Nellcor-OXIMAX/New finger clip/Adult/1.1M/103X
Unimed Medical Supplies, Inc.
U403N-01P
In Commercial Distribution

  • 06945664828758 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664828680

Reusable SpO2 Sensor/Nellcor/ New Finger Clip/Adult/1.1M/DB9M
Unimed Medical Supplies, Inc.
U403N-01XP
In Commercial Distribution

  • 06945664828680 ()


  • Pulse oximeter probe, reusable

NIOX - 07350047030496

Disposable patient filter for use with the NIOX VERO device to be changed for each new measurement session and for each new patient.
Circassia AB
VERO Filter
In Commercial Distribution

  • 07350047030496 ()
  • 7350047030489 ()
  • 7350047030502 ()
  • 07350047030199 ()
12-1018

  • Pulmonary function testing filter/mouthpiece

chemagic 360-D - 06438147356706

The chemagic 360-D is an automated laboratory instrument used in preanalytical preparation of samples through magnetic particle separation technology for use with in vitro diagnostic clinical sample concentrating kits. The instrument is intended for use by healthcare professionals such as laboratory personnel or physicians who are trained in molecular biology techniques.
Wallac Oy
2024-0010
In Commercial Distribution

  • 06438147356706 ()
2024-0010

  • Magnetic particle separation instrument IVD

chemagic Prepito -D - 06438147332205

The chemagic Prepito-D is an automated laboratory instrument used in preanalytical preparation of samples through magnetic particle separation technology for use with in vitro diagnostic clinical sample concentrating kits. The instrument is intended for use by healthcare professionals such as laboratory personnel or physicians who are trained in molecular biology techniques.
Wallac Oy
2022-0020
In Commercial Distribution

  • 06438147332205 ()
2022-0020

  • Magnetic particle separation instrument IVD

Maxwell® CSC 48 Instrument - 00849811060991

The Maxwell® CSC 48 Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perform automated isolation of nucleic acids from biological samples.
PROMEGA CORPORATION
AS8000
In Commercial Distribution

  • 00849811060991 ()
AS8000

  • Magnetic particle separation instrument IVD

Maxwell® CSC Instrument - 00849811051340

The Maxwell® CSC Instrument is a nucleic acid extraction instrument used in combination with Maxwell® CSC reagent kits to perform automated isolation of nucleic acids from biological samples.
PROMEGA CORPORATION
AS6000
In Commercial Distribution

  • 00849811051340 ()
AS6000

  • Magnetic particle separation instrument IVD

T2Dx® - M70870049330

Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top housing.
T2 BIOSYSTEMS, INC.
70-04933
In Commercial Distribution

  • M70870049330 ()


  • Magnetic particle separation instrument IVD

CHROMA ATE - 04719889100010

MagXtract 3200 Automated Nucleic Acid Extraction System The MagXtract 3200 system is an automated nucleic acid purification and PCR reaction preparation system consisting of MagXtract 3200 instrument, software and consumables. It must be used in combination with the authorized extraction kits which have been validated according to the IVD or other relevant regulations to perform the nucleic acid purifications. The MagXtract 3200 System is intended for use by professional users for the purification of nucleic acids and PCR sample prep from human samples for in vitro diagnostic purposes. Product Use Limitations: The MagXtract 3200 instrument is intended for indoor use only. The user is responsible for establishing performance characteristics necessary for downstream diagnostic applications. Appropriate controls must be included in any downstream diagnostic applications using nucleic acids, purified by the instruments.
CHROMA ATE INC.
MagXtract 3200
In Commercial Distribution

  • 04719889100010 ()


  • Magnetic particle separation instrument IVD

Fisher & Paykel Healthcare - 09420012424990

INFOSMART CD
FISHER & PAYKEL HEALTHCARE LIMITED
900SW100
In Commercial Distribution

  • 09420012424990 ()
900SW100

  • Ventilator application software

AVEA™ - 10190752175921

AVEA NIMV+VG SW KEY
VYAIRE MEDICAL, INC.
63865
In Commercial Distribution

  • 10190752175921 ()
63865

  • Ventilator application software

ResScan - 00619498313365

ResScan V6.1 CD ASSY
RESMED PTY LTD
31336
In Commercial Distribution

  • 00619498313365 ()
31336

  • Ventilator application software

ResScan - 00619498313358

RESSCAN V6.0.2 CD ASSY
RESMED PTY LTD
31335
In Commercial Distribution

  • 00619498313358 ()
31335

  • Ventilator application software

ResScan - 00619498313341

RESSCAN V6.0.1 CD ASSY
RESMED PTY LTD
31334
In Commercial Distribution

  • 00619498313341 ()
31334

  • Ventilator application software

ResScan - 00619498313334

RESSCAN V6.0 CD ASSY
RESMED PTY LTD
31333
In Commercial Distribution

  • 00619498313334 ()
31333

  • Ventilator application software

ResScan - 00619498313327

RESSCAN V 5.9 CD ASSY
RESMED PTY LTD
31332
In Commercial Distribution

  • 00619498313327 ()
31332

  • Ventilator application software

ResScan - 00619498313303

RESSCAN V 5.8 CD ASSY
RESMED PTY LTD
31330
In Commercial Distribution

  • 00619498313303 ()
31330

  • Ventilator application software

ResScan - 00619498313297

RESSCAN V 5.7 CD ASSY
RESMED PTY LTD
31329
In Commercial Distribution

  • 00619498313297 ()
31329

  • Ventilator application software

RESSCAN - 00619498313273

RESSCAN V 5.5 CD ASSY
RESMED PTY LTD
31327
In Commercial Distribution

  • 00619498313273 ()
31327

  • Ventilator application software
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