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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AEROAUTOCAT2 ITALIAN
TELEFLEX INCORPORATED
IPN000316
In Commercial Distribution

  • 30801902092121 ()
  • 00801902092120 ()
IAP-0435I

  • Intra-aortic balloon pump
AUTOCAT2 ITALIAN
TELEFLEX INCORPORATED
IPN000307
In Commercial Distribution

  • 30801902092060 ()
  • 00801902092069 ()
IAP-0400I

  • Intra-aortic balloon pump
EyeMax2 Preemie Italian 20/Pack (Italian Label)
MAXTEC, LLC
Preemie
In Commercial Distribution

  • 00817770025825 ()
R300P02-004

  • Phototherapy infant blanket
EyeMax2 Micro 20/Pack Italian (Italian Label)
MAXTEC, LLC
Micro
In Commercial Distribution

  • 00817770025818 ()
R300P03-004

  • Phototherapy infant blanket
ASSY CRM ITALIAN
Datascope Corp.
0997-00-0986-07
In Commercial Distribution

  • 10607567110714 ()
0997-00-0986-07

  • Intra-aortic balloon pump
MIXER,GENERAL,ITALIAN
SECHRIST INDUSTRIES, INC.
3500CP-G3
In Commercial Distribution

  • 00899660002789 ()

  • Weight: 3 Pound
  • Height: 6 Inch
  • Width: 4 Inch
  • Depth: 5 Inch


  • Oxygen/air breathing gas mixer, hospital
THICK ITALIAN NUT
Smith & Nephew, Inc.
71070286
In Commercial Distribution

  • 20885556119376 ()
  • 00885556119372 ()
71070286

  • External orthopaedic fixation system, single-use
AUTOCAT2 WAVE ITALIAN
TELEFLEX INCORPORATED
IPN000324
In Commercial Distribution

  • 30801902092190 ()
  • 00801902092199 ()
IAP-0500I

  • Intra-aortic balloon pump
AEROAUTOCAT2 WAVE ITALIAN
TELEFLEX INCORPORATED
IPN000333
In Commercial Distribution

  • 30801902091773 ()
  • 00801902091772 ()
IAP-0535I

  • Intra-aortic balloon pump
THICK ITALIAN NUT
Smith & Nephew, Inc.
71930333
In Commercial Distribution

  • 20885556051591 ()
  • 00885556051597 ()
71930333

  • External orthopaedic fixation system, single-use
ASSY,SAFETY DISK, ITALIAN
Datascope Corp.
0997-00-0985-07
In Commercial Distribution

  • 10607567110707 ()
0997-00-0985-07

  • Intra-aortic balloon pump
DYONICS PWR HERMES ITALIAN
Smith & Nephew, Inc.
7210199
In Commercial Distribution

  • 00885556539668 ()
7210199

  • Arthroscopic shaver system, electrically-powered
KIT ITALIAN 660HD-E IMS
Smith & Nephew, Inc.
72204708
In Commercial Distribution

  • 00885556623756 ()
72204708

  • Endoscopic video imaging system
KIT DYONICS 25 ITALIAN
Smith & Nephew, Inc.
72200223
Not in Commercial Distribution

  • 00885554011609 ()
72200223

  • Arthroscopic irrigation/insufflation system
To be used with ATTIVA device (K220505).
ITALIAN ENGINEERING SRL
CBEL-R-IE
In Commercial Distribution

  • 05060224334072 ()

  • Length: 200 Millimeter


  • Electrosurgical cable adaptor
The electrode thermocouple measures temperature and, through a feedback circuit, automatically adjusting energy delivery to maintain the set temperature in the tissue. To be used with ATTIVA device (K220505)
ITALIAN ENGINEERING SRL
RFEL-R150-IE
In Commercial Distribution

  • 05060224334003 ()

  • Catheter Length: 150 Millimeter


  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
The electrode thermocouple measures temperature and, through a feedback circuit, automatically adjusting energy delivery to maintain the set temperature in the tissue. To be used with ATTIVA device (K220505).
ITALIAN ENGINEERING SRL
RFEL-R100-IE
In Commercial Distribution

  • 05060224333990 ()

  • Catheter Length: 100 Millimeter


  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
The electrode thermocouple measures temperature and, through a feedback circuit, automatically adjusting energy delivery to maintain the set temperature in the tissue. To be used with ATTIVA device (K220505)
ITALIAN ENGINEERING SRL
RFEL-R50-IE
In Commercial Distribution

  • 05060224333983 ()

  • Catheter Length: 50 Millimeter


  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
RF BLUNT STRAIGHT CANNULA, 22G x 100mm, ACTIVE TIP 10mm with Holder. Cannulas are closed-end tip, so that the electrodes are never in contact with the patient as they are internal to the closed-end tip cannulas. To be used only with ATTIVA device (K220505).
ITALIAN ENGINEERING SRL
RF0M22100R10A
In Commercial Distribution

  • 08055510890131 ()


  • Percutaneous radio-frequency ablation probe cannula, single-use
ATTIVA is a Radiofrequency (RF) System (generator, electrodes/handpieces and accessories) indicated for treatments based on the emission of electromagnetic waves that lead to a rise of internal temperature of tissues involved in the treatment for electrocoagulation and hemostasis. ATTIVA device can be used on adult patients only. It comprises of a base unit, activation pedal, ground pad (K203494), endodermic handpiece, thermal camera (K033967) and monitor, and blunt cannulas and RF electrodes.
ITALIAN ENGINEERING SRL
MD01
In Commercial Distribution

  • 08055510890087 ()

  • Weight: 5.8 Kilogram
  • Length: 38.5 Centimeter
  • Height: 10 Centimeter
  • Width: 20.5 Centimeter


  • Percutaneous radio-frequency ablation system generator
RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm with Holder. This includes: - RF0M22050R10A - RF0M22100R10A - RF0M20150R10A - RF0M16200R10A. Cannulas are closed-end tip, so that the electrodes are never in contact with the patient as they are internal to the closed-end tip cannulas. To be used only with ATTIVA device (K220505).
ITALIAN ENGINEERING SRL
RF0MXXYYYRZZA
In Commercial Distribution

  • 08058341213919 ()


  • Percutaneous radio-frequency ablation probe cannula, single-use
RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm without Holder. This includes: - RF0M22050R10 - RF0M22100R10 - RF0M20150R10 - RF0M16200R10. Cannulas are closed-end tip, so that the electrodes are never in contact with the patient as they are internal to the closed-end tip cannulas. They are to be used only with ATTIVA device (K220505).
ITALIAN ENGINEERING SRL
RF0MXXYYYRZZ
In Commercial Distribution

  • 08058341218716 ()


  • Percutaneous radio-frequency ablation probe cannula, single-use
The electrode thermocouple measures temperature and, through a feedback circuit, automatically adjusting energy delivery to maintain the set temperature in the tissue. To be used with ATTIVA device (K220505).
ITALIAN ENGINEERING SRL
RFEL-R200-IE
In Commercial Distribution

  • 05060224334010 ()

  • Catheter Length: 200 Millimeter


  • Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
Power Control Console, Italian Voice
OSTEOMED LLC
450-0021-02
In Commercial Distribution

  • 00845694012171 ()
450-0021-02

  • General internal orthopaedic fixation system implantation kit
ASSY, LTV1150, W/ ACCESS, ITALIAN
Carefusion Corporation
18984-005
Not in Commercial Distribution

  • 00845873002733 ()


  • Transport electric ventilator
ASSY, LTV1200, W/ ACCESS, ITALIAN
Carefusion Corporation
18888-005
Not in Commercial Distribution

  • 00845873002634 ()


  • Transport electric ventilator
The Logan Italian Plum Spectacle
Kenmark Optical, Inc.
LOGAPL52
In Commercial Distribution

  • 00715317975094 ()


  • Prescription spectacles
MTO DYONICS POWER ITALIAN KIT
Smith & Nephew, Inc.
7205892
Not in Commercial Distribution

  • 03596010430908 ()
7205892

  • Surgical power tool system control unit, line-powered
System, Med4 Elite, Switzerland, Italian
Avanos Medical, Inc.
650500-IT06
In Commercial Distribution

  • 00812120002860 ()


  • Circulating-fluid localized thermal/compression therapy system control unit
System, Med4 Elite, Italy, Italian
Avanos Medical, Inc.
650500-IT04
In Commercial Distribution

  • 00812120002709 ()


  • Circulating-fluid localized thermal/compression therapy system control unit
Precision Flow Heliox UKIT, Italian
VAPOTHERM, INC.
PFH-UKIT-C-IT
In Commercial Distribution

  • 00841737103554 ()


  • Electrical mains power cable
  • Respiratory oxygen sensor
KIT ITALIAN DYONICS POWER II
Smith & Nephew, Inc.
72201045
Not in Commercial Distribution

  • 00885554014884 ()
72201045

  • Electrical-only medical device connection cable, reusable
KIT ITALIAN 560P HD CCU
Smith & Nephew, Inc.
72200593
In Commercial Distribution

  • 00885554013634 ()
72200593

  • Camera control unit
Sleep Profiler LE Device Kit Italian
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(ITA)
In Commercial Distribution

  • 00850015266522 ()


  • Electroencephalograph
Arm & Chin EMG Cable Kit Italian
ADVANCED BRAIN MONITORING, INC.
SP29-4001.LE(ITA)
In Commercial Distribution

  • 00850015266577 ()


  • Analytical non-scalp cutaneous lead
  • Electrocardiographic lead set, reusable
Night Shift Chest Belt Kit - Italian
ADVANCED BRAIN MONITORING, INC.
NS27-4102(ITA)
In Commercial Distribution

  • 00850015266133 ()


  • Behavioural therapy electrical stimulation system
26P ProFlexx®, Italian w/Mattress
FERNO-WASHINGTON, INC.
0054208
Not in Commercial Distribution

  • 00190790000592 ()


  • Ambulance stretcher, manual
4 ELECTRODE EVO RECORDER, PACKED, ITALIAN
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124792 ()
50-0034-04

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

  • 00896128002732 ()


  • Conduction blood/fluid warmer
MTO TRIVEX TM ITALIAN KIT 230-240V
Smith & Nephew, Inc.
7205944
Not in Commercial Distribution

  • 03596010442154 ()
7205944

  • Transillumination phlebectomy system control unit
EyeMax2 Regular 20/Pack (Italian Label)
MAXTEC, LLC
Regular
In Commercial Distribution

  • 00817770025832 ()
R300P01-004

  • Phototherapy infant blanket
CS100 Intra-Aortic Balloon Pump, Italian, 220V
Datascope Corp.
0998-00-3013-67
Not in Commercial Distribution

  • 10607567107486 ()
0998-00-3013-67

  • Intra-aortic balloon pump
CS100 Accessory Kit, Italian, 220 V
Datascope Corp.
0020-00-0463-07
Not in Commercial Distribution

  • 10607567112626 ()
0020-00-0463-07

  • Intra-aortic balloon pump
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
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