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 Class Implantable

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CS300 Intra-Aortic Balloon Pump, Italian, 220V
Datascope Corp.
0998-00-3023-67
In Commercial Distribution

  • 10607567112619 ()
0998-00-3023-67

  • Intra-aortic balloon pump
CS300 Accessory Kit, Italian, 220 V
Datascope Corp.
0020-00-0482-07
In Commercial Distribution

  • 10607567108476 ()
0020-00-0482-07

  • Intra-aortic balloon pump
Night Shift LE Device Kit - Italian
ADVANCED BRAIN MONITORING, INC.
NS27-1005.LE(ITA)
In Commercial Distribution

  • 60850015266197 ()


  • Behavioural therapy electrical stimulation system
Italian Cypress -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386079
In Commercial Distribution

  • 00630414965963 ()
T23L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
KIT ITALIAN LENS INTEGRATED SYSTEM NON-WIFI
Smith & Nephew, Inc.
72204897
In Commercial Distribution

  • 00885556618073 ()
72204897

  • Endoscopic video imaging system
S&N 400 INSUFFLATOR KIT ITALIAN
Smith & Nephew, Inc.
7209943
In Commercial Distribution

  • 00885554011821 ()
7209943

  • Laparoscopic insufflator
No Description
Respironics Novametrix, LLC
7900
In Commercial Distribution

  • 00884838015654 ()
1060460

  • Monitoring spirometer, electrical
Dual Lead Cable 40" 3-Pin Kit Italian
ADVANCED BRAIN MONITORING, INC.
UN03-4008(ITA)
In Commercial Distribution

  • 00850015266584 ()


  • Analytical non-scalp cutaneous lead
  • Electrocardiographic lead set, reusable
4 ELECTRODE EVO, BELT MOUNTED, PACKED ITALIAN
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124891 ()
50-0035-04

  • Electrocardiographic ambulatory recorder
buddy, 230V SYSTEM, ITALIAN, STANDARD EUROPEAN CORD
BELMONT INSTRUMENT CORPORATION
905-00001A-I-SE
Not in Commercial Distribution

  • 00896128002688 ()


  • Conduction blood/fluid warmer
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