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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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It's designed for family and individual users to track heart activity at home, at work or on a trip in case of cardiac situation that needs evaluation on the spot.
EMAY (HK) LIMITED
EMG-20
In Commercial Distribution

  • 04897087200203 ()


  • Electrocardiographic monitor
It's designed for family and individual users to track heart activity at home, at work or on a trip in case of cardiac situation that needs evaluation on the spot.
EMAY (HK) LIMITED
EMG-10
Not in Commercial Distribution

  • 04897087200104 ()


  • Electrocardiographic monitor
The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at both levels.
RANDOX LABORATORIES LIMITED
HS2611
In Commercial Distribution

  • 05055273203813 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at both levels.
RANDOX LABORATORIES LIMITED
HN1530
In Commercial Distribution

  • 05055273203783 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at both levels.
RANDOX LABORATORIES LIMITED
HE1532
In Commercial Distribution

  • 05055273203608 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
Miyoshi Ultimate Vertical Dual Flow Hydrodissectional Cannula 25ga, Angled 45 Degrees at 1.5mm bend to tip, .2mm Dual Ports set at 120 Degrees, Smooth closed sandblasted tip, 22mm Overall Length
Crestpoint Management Limited
CA1628
In Commercial Distribution

  • G412CA16280 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Miyoshi Ultimate Vertical Dual Flow Hydrodissectional Cannula 23ga, Angled 45 Degrees at 1.5mm bend to tip, .2mm Dual Ports set at 120 Degrees, Smooth closed sandblasted tip, 22mm Overall Length
Crestpoint Management Limited
CA1627
In Commercial Distribution

  • G412CA16270 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 36 months at 22.5°C.
Temptime Corporation
CT36
In Commercial Distribution

  • 00852282007136 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 22.5°C.
Temptime Corporation
CT12
In Commercial Distribution

  • 00852282007129 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 24 months at 22.5°C.
Temptime Corporation
CT24
In Commercial Distribution

  • 00852282007112 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 9 months at 22.5°C.
Temptime Corporation
CT9
In Commercial Distribution

  • 00852282007105 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 182 days at 22.5°C.
Temptime Corporation
CT6
In Commercial Distribution

  • 00852282007099 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 121 days at 22.5°C.
Temptime Corporation
CT4
In Commercial Distribution

  • 00852282007082 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 22.5°C.
Temptime Corporation
CT3
In Commercial Distribution

  • 00852282007075 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 60 days at 22.5°C.
Temptime Corporation
CT2
In Commercial Distribution

  • 00852282007068 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 36 months at 5°C.
Temptime Corporation
F36
In Commercial Distribution

  • 00852282007051 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 24 months at 5°C.
Temptime Corporation
F24
In Commercial Distribution

  • 00852282007044 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 5°C.
Temptime Corporation
F12
In Commercial Distribution

  • 00852282007037 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 9 months at 5°C.
Temptime Corporation
F9
In Commercial Distribution

  • 00852282007020 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 182 days at 5°C.
Temptime Corporation
F6
In Commercial Distribution

  • 00852282007013 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 5°C.
Temptime Corporation
F3
In Commercial Distribution

  • 00852282007006 ()


  • Medical product temperature point indicator, thermochemical
ProMax Surgical Gown, MLR Front Yoke with Kaumograph, Comfort Panel Back with Negastat, Color Coded Neck Binding, Snap Closures at Neck, Color Coded Tie Closures at Waist, With QCM, Size XL
STANDARD TEXTILE CO., INC.
75615074
In Commercial Distribution

  • 10634916819035 ()
  • 00634916819038 ()


  • Surgical gown, reusable
ProMax Surgical Gown, MLR Front Yoke with Kaumograph, Comfort Panel Back with Negastat, Color Coded Neck Binding, Snap Closures at Neck, Color Coded Tie Closures at Waist, With QCM, Size Large
STANDARD TEXTILE CO., INC.
75615075
In Commercial Distribution

  • 10634916819028 ()
  • 00634916819021 ()


  • Surgical gown, reusable
VMS Left Posterior Aiming Device (Re-Use): Used to score the femoral neck at 45°.
ELITE SURGICAL SUPPLIES (PTY) LTD
VMSAD14
In Commercial Distribution

  • 06009712290413 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
VMS Right Posterior Aiming Device (Re-Use): Used to score the femoral neck at 45°.
ELITE SURGICAL SUPPLIES (PTY) LTD
VMSAD13
In Commercial Distribution

  • 06009712290406 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
VMS Left Anterior Aiming Device (Re-Use): Used to score the femoral neck at 45°
ELITE SURGICAL SUPPLIES (PTY) LTD
VMSAD12
In Commercial Distribution

  • 06009712290390 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
VMS Right Anterior Aiming Device (Re-Use): Used to score the femoral neck at 45°.
ELITE SURGICAL SUPPLIES (PTY) LTD
VMSAD11
In Commercial Distribution

  • 06009712290383 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
The IV Armboard without Pad with Velcro Straps supports arm at a comfortable angle.
STERIS CORPORATION
Arm Support
In Commercial Distribution

  • 00724995156916 ()
BF141

  • Arm procedure positioner, reusable
Infrared phototherapy device emitting up to 10 W at 810/980 nm, 7" display
LITECURE LLC
LTC-1001-L-B6
In Commercial Distribution

  • 00854103007295 ()


  • Musculoskeletal/physical therapy laser, professional
Infrared phototherapy device emitting up to 8W at 810/980nm, battery option, 10" display
LITECURE LLC
LTC-1510-SOLA
In Commercial Distribution

  • 00854103007066 ()


  • Musculoskeletal/physical therapy laser, professional
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