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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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Timm Medical - 00857312008183

No Description
POS-T-VAC INC
Esteem Cylinder with Insert
In Commercial Distribution

  • 00857312008183 ()
1250

  • Penile vacuum device

Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software - 00664369000639

Fully Automated Urine Cell Analyzer UF-1000i UF WAM
Sysmex America, Inc.
UF-1000i with UF WAM
In Commercial Distribution

  • 00664369000639 ()


  • Flow cytometry analyser IVD

MasterScope - 04057155000641

diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
eResearchTechnology GmbH
MasterScope WSSU with ECG
In Commercial Distribution

  • 04057155000641 ()


  • Diagnostic spirometer, professional
  • Electrocardiograph, professional, multichannel

MasterScope - 04057155000627

diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
eResearchTechnology GmbH
MasterScope CT with ECG
In Commercial Distribution

  • 04057155000627 ()


  • Diagnostic spirometer, professional
  • Electrocardiograph, professional, multichannel

MasterScope - 04057155000030

diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
eResearchTechnology GmbH
MasterScope CT with ECG
In Commercial Distribution

  • 04057155000030 ()


  • Diagnostic spirometer, professional
  • Electrocardiograph, professional, multichannel

Revolution Apex - 00195278788665

Revolution Apex Select with Plus Edition - Designated System Medical Device
Hangwei GE Medical Systems Co., Ltd.
Select with Plus Edition
In Commercial Distribution

  • 00195278788665 ()
B7919YO

  • Full-body CT system

Aisys - 00195278588128

AISYS CS2 WITH ET CONTROL
DATEX-OHMEDA INC
CS2 WITH ET CONTROL
In Commercial Distribution

  • 00195278588128 ()


  • Anaesthesia workstation, general-purpose

Revolution CT - 00195278471277

Revolution CT ES with Apex edition - Designated System Medical Device
GE MEDICAL SYSTEMS, INC.
ES with Apex edition
In Commercial Distribution

  • 00195278471277 ()
5826588

  • Full-body CT system

All Soft Ureteral Stent - 7F, 26cm with Suture - 00812261015279

All Soft Ureteral Stent - 7F, 26cm with Suture
ALLWIN MEDICAL DEVICES, INC.
7F, 26cm with Suture
In Commercial Distribution

  • 10812261015276 ()
  • 00812261015279 ()
SOT 7/26-S

  • Polymeric ureteral stent

All Soft Ureteral Stent - 6F, 26cm with Suture - 00812261013756

All Soft Ureteral Stent - 6F, 26cm with Suture
ALLWIN MEDICAL DEVICES, INC.
6F, 26cm with Suture
In Commercial Distribution

  • 10812261013753 ()
  • 00812261013756 ()
SOT 6/26-S

  • Polymeric ureteral stent
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