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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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
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
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
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
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
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MINI - Bianco
In Commercial Distribution

  • 08052675320008 ()
IT17-002

  • Orthodontic extraoral headgear
Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) Italian
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(ITA)
In Commercial Distribution

  • 00850015266874 ()
  • 00851113007949 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
Sleep Profiler LE Device Kit (Arm&Chin EMG) Italian
ADVANCED BRAIN MONITORING, INC.
SP29-1014.LE(ITA)
In Commercial Distribution

  • 00850015266607 ()


  • Electroencephalograph
Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) Italian
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(ITA)
In Commercial Distribution

  • 00850063034241 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
Compact Series Ultrasound System Cart
Philips Ultrasound LLC
989606735271
In Commercial Distribution

  • 00884838111981 ()


  • General-purpose ultrasound imaging system
Compact Series Ultrasound System Cart
Philips Ultrasound LLC
989606735151
In Commercial Distribution

  • 00884838111868 ()


  • General-purpose ultrasound imaging system
Compact Series Ultrasound System Cart
Philips Ultrasound LLC
989606735021
In Commercial Distribution

  • 00884838111738 ()


  • General-purpose ultrasound imaging system
No Description
BELMONT INSTRUMENT CORPORATION
902-00001A-I
Not in Commercial Distribution

  • 50896128002133 ()


  • Extravascular-circulation hyperthermia system
self-contained biological indicator, 10e6 population, 100-count box printed in Italian
MESA LABORATORIES, INC.
10e6
In Commercial Distribution

  • M985IDSEZS61 ()
  • M985IDSEZS60 ()
IDSEZS/6

  • Biological sterilization indicator
self-contained biological indicator, 10e6 population, 100-count box printed in Italian
MESA LABORATORIES, INC.
10e6
In Commercial Distribution

  • M985IDEZS61 ()
  • M985IDEZS60 ()
IDEZS/6

  • Biological sterilization indicator
self-contained biological indicator, 10e5 population, 100-count box printed in Italian
MESA LABORATORIES, INC.
10e5
In Commercial Distribution

  • M985IDEZS51 ()
  • M985IDEZS50 ()
IDEZS/5

  • Biological sterilization indicator
Visible Light-Cured Restorative, Resin Based. Universal Bonding Agent. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-121 I
In Commercial Distribution

  • D801ID50121I1 ()
50-121

  • Dental composite resin
e-vive II NMES System with Post-Op Brace; 2XL/3XL, Left (ITALIAN)
Motive Health, Inc.
CY-1000-312I
In Commercial Distribution

  • 00850022650055 ()

  • Length: 16 Inch
CY-1000-312I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System with Post-Op Brace; L/XL, Left (ITALIAN)
Motive Health, Inc.
CY-1000-311I
In Commercial Distribution

  • 00850022650048 ()

  • Length: 16 Inch
CY-1000-311I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System with Post-Op Brace; S/M, Left (ITALIAN)
Motive Health, Inc.
CY-1000-310I
In Commercial Distribution

  • 00850022650031 ()

  • Length: 16 Inch
CY-1000-310I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System with Post-Op Brace; 2XL/3XL, Right (ITALIAN)
Motive Health, Inc.
CY-1000-309I
In Commercial Distribution

  • 00850022650024 ()

  • Length: 16 Inch
CY-1000-309I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System with Post-Op Brace; L/XL, Right (ITALIAN)
Motive Health, Inc.
CY-1000-308I
In Commercial Distribution

  • 00850022650017 ()

  • Length: 16 Inch
CY-1000-308I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System with Post-Op Brace; S/M, Right (ITALIAN)
Motive Health, Inc.
CY-1000-307I
In Commercial Distribution

  • 00850022650000 ()

  • Length: 16 Inch
CY-1000-307I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Enamel Primer Bottle. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-052 I
In Commercial Distribution

  • D801ID60052I1 ()
60-052

  • Dentine adhesive
IDS Dental Polishing Paste for Composite Restoratives, Amalgams, and Castings. Italian
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-05
In Commercial Distribution

  • D801ID5005I1 ()
50-05

  • Dentifrice
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