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

  • 10841522124792 ()
50-0034-04

  • Electrocardiographic ambulatory recorder
EyeMax2 Regular 20/Pack (Italian Label)
MAXTEC, LLC
Regular
In Commercial Distribution

  • 00817770025832 ()
R300P01-004

  • Phototherapy infant blanket
Night Shift LE Device Kit - Italian
ADVANCED BRAIN MONITORING, INC.
NS27-1005.LE(ITA)
In Commercial Distribution

  • 60850015266197 ()


  • Behavioural therapy electrical stimulation system
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
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
CS300 Accessory Kit, Italian, 220 V
Datascope Corp.
0020-00-0482-07
In Commercial Distribution

  • 10607567108476 ()
0020-00-0482-07

  • Intra-aortic balloon pump
S&N 400 INSUFFLATOR KIT ITALIAN
Smith & Nephew, Inc.
7209943
In Commercial Distribution

  • 00885554011821 ()
7209943

  • Laparoscopic insufflator
KIT ITALIAN LENS INTEGRATED SYSTEM NON-WIFI
Smith & Nephew, Inc.
72204897
In Commercial Distribution

  • 00885556618073 ()
72204897

  • Endoscopic video imaging system
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
Power Control Console with Irrigation, Italian Voice
OSTEOMED LLC
450-0005-02
In Commercial Distribution

  • 00845694012133 ()
450-0005-02

  • General internal orthopaedic fixation system implantation kit
buddy, 230V SYSTEM, ITALIAN, STANDARD EUROPEAN CORD
BELMONT INSTRUMENT CORPORATION
905-00001A-I-SE
Not in Commercial Distribution

  • 00896128002688 ()


  • Conduction blood/fluid warmer
4 ELECTRODE EVO, BELT MOUNTED, PACKED ITALIAN
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522124891 ()
50-0035-04

  • Electrocardiographic ambulatory recorder
Power Cord, Med4 Elite, CEI 23-16 Italian
Avanos Medical, Inc.
303838
In Commercial Distribution

  • 00812120002525 ()


  • Circulating-fluid localized thermal/compression therapy system control unit
CS100 UTS Intra-Aortic Balloon Pump ITALIAN 220V
Datascope Corp.
0998-00-3013-97
Not in Commercial Distribution

  • 10607567108162 ()
0998-00-3013-97

  • Intra-aortic balloon pump
CS300 Intra-Aortic Balloon Pump - UTS, Italian, 220V
Datascope Corp.
0998-00-3023-97
In Commercial Distribution

  • 10607567108346 ()
0998-00-3023-97

  • Intra-aortic balloon pump
ImmunoCAP Allergen t23, Italian/Mediterranean/Funeral cypress
Phadia AB
14-4237-01
In Commercial Distribution

  • 07333066002347 ()
14-4237-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
KIT ITALIAN LENS 4K CCU WIFI VERSION
Smith & Nephew, Inc.
72205229
In Commercial Distribution

  • 00885556731178 ()
72205229

  • Camera control unit
KIT ITALIAN LENS 4K CCU NON WIFI
Smith & Nephew, Inc.
72205257
In Commercial Distribution

  • 00885556730898 ()
72205257

  • Camera control unit
e-vive II NMES System; 2XL/3XL, Left (ITALIAN)
Motive Health, Inc.
CY-1000-318I
In Commercial Distribution

  • 00850022650116 ()

  • Length: 16 Inch
CY-1000-318I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System; L/XL, Left (ITALIAN)
Motive Health, Inc.
CY-1000-317I
In Commercial Distribution

  • 00850022650109 ()

  • Length: 16 Inch
CY-1000-317I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System; S/M, Left (ITALIAN)
Motive Health, Inc.
CY-1000-316I
In Commercial Distribution

  • 00850022650093 ()

  • Length: 16 Inch
CY-1000-316I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System; 2XL/3XL, Right (ITALIAN)
Motive Health, Inc.
CY-1000-315I
In Commercial Distribution

  • 00850022650086 ()

  • Length: 16 Inch
CY-1000-315I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System; L/XL, Right (ITALIAN)
Motive Health, Inc.
CY-1000-314I
In Commercial Distribution

  • 00850022650079 ()

  • Length: 16 Inch
CY-1000-314I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System; S/M, Right (ITALIAN)
Motive Health, Inc.
CY-1000-313I
In Commercial Distribution

  • 00850022650062 ()

  • Length: 16 Inch
CY-1000-313I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
800 Series Options Kit, Italian, 840 Neonatal Ventilator
Covidien LP
10051463
Not in Commercial Distribution

  • 10884521640887 ()


  • Ventilator application software
CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Kit. Italian
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-05 I
In Commercial Distribution

  • D801ID6005I1 ()
60-05

  • Dentine adhesive
CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Syringe. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-051 I
In Commercial Distribution

  • D801ID60051I1 ()
60-05

  • Dentine adhesive
CS300 Intra-Aortic Balloon Pump, Refurbished, ITALIAN,NON-UTS,INTL
Datascope Corp.
0998-UC-3023-67
In Commercial Distribution

  • 10607567108810 ()
0998-UC-3023-67

  • Intra-aortic balloon pump
CS100 Intra-Aortic Balloon Pump, Refurbished, ITALIAN,NON-UTS,INTL
Datascope Corp.
0998-UC-3013-67
Not in Commercial Distribution

  • 10607567108681 ()
0998-UC-3013-67

  • Intra-aortic balloon pump
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MAXI - Verde
In Commercial Distribution

  • 08052675320091 ()
IT17-001V

  • Orthodontic extraoral headgear
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MAXI - Rosso
In Commercial Distribution

  • 08052675320084 ()
IT17-001R

  • Orthodontic extraoral headgear
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MAXI - Giallo
In Commercial Distribution

  • 08052675320077 ()
IT17-001G

  • Orthodontic extraoral headgear
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica MAXI Blu
In Commercial Distribution

  • 08052675320060 ()
IT17-001B

  • Orthodontic extraoral headgear
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MAXI - Bianco
In Commercial Distribution

  • 08052675320053 ()
IT17-001

  • Orthodontic extraoral headgear
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MINI - Verde
In Commercial Distribution

  • 08052675320046 ()
IT17-002V

  • Orthodontic extraoral headgear
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MINI - Rosso
In Commercial Distribution

  • 08052675320039 ()
IT17-002R

  • Orthodontic extraoral headgear
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MINI - Giallo
In Commercial Distribution

  • 08052675320022 ()
IT17-002G

  • Orthodontic extraoral headgear
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MINI - Blu
In Commercial Distribution

  • 08052675320015 ()
IT17-002B

  • Orthodontic extraoral headgear
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