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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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TintoFast Prame is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3774-15
In Commercial Distribution

  • B502BSB3774150 ()

  • Total Volume: 15 Milliliter
BSB-3774-15

  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
WALG CRUTCH ACCESSORY KIT(2 Arm Cushions, 2 Hand Grips, 2 Tips)
WALGREEN CO.
586508
In Commercial Distribution

  • 00311917212715 ()
  • 10311917212712 ()


  • Walking aid handgrip
  • Walking aid tip
  • Crutch pad
WALG CRUTCH ACCESSORY KIT
WALGREEN CO.
954484
In Commercial Distribution

  • 10311917187560 ()
  • 00311917187563 ()


  • Walking aid handgrip
  • Walking aid tip
  • Crutch pad
IN Clips
BHI IMPLANTS LTD
1
In Commercial Distribution

  • 07290109742427 ()
BH-IB81

  • Dental implant suprastructure, permanent, preformed
Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible with 230 Volts power outlet. 3D field of view of 17.2 cm (height) x 16cm (diameter) accommodates imaging of hand, wrist, forearm, elbow, knee, lower leg or foot. Bore platforms are interchangeable to accommodate patient size and body part. Self-shielded to reduce scatter radiation during scan. Scan time is less than 30 seconds. Scans are output as DICOM compatible 3D reconstructions, 0.2 mm multi-planar slices. In Reach system includes acquisition station and visualization station enabled with CubeVue visualization software.
CURVEBEAM, LLC
1020-230
In Commercial Distribution

  • 00863152000331 ()


  • Limited-view-field CT system
Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible with 115 Volts power outlet. 3D field of view of 17.2 cm (height) x 16cm (diameter) accommodates imaging of hand, wrist, forearm, elbow, knee, lower leg or foot. Bore platforms are interchangeable to accommodate patient size and body part. Self-shielded to reduce scatter radiation during scan. Scan time is less than 30 seconds. Scans are output as DICOM compatible 3D reconstructions, 0.2 mm multi-planar slices. In Reach system includes acquisition station and visualization station enabled with CubeVue visualization software.
CURVEBEAM, LLC
1020-115
In Commercial Distribution

  • 00863152000324 ()


  • Limited-view-field CT system
No Description
Freudenberg Medical, LLC
IN 4063
In Commercial Distribution

  • 00848253004020 ()
IN 4063

  • Airway device cleaning utensil, invasive
No Description
Freudenberg Medical, LLC
IN 4062
In Commercial Distribution

  • 00848253004013 ()
IN 4062

  • Airway device cleaning utensil, invasive
INTRODUCER NEEDLE 100MM PER AGO 14G
H.S. HOSPITAL SERVICE SPA
INTRODUCER NEEDLE
In Commercial Distribution

  • 48033055147291 ()
  • 08033055147293 ()

  • Length: 100 Millimeter
IN 14100N

  • Interventional radiology percutaneous-access kit, single-use
INTRODUCER NEEDLE 150MM PER AGO 16G
H.S. HOSPITAL SERVICE SPA
INTRODUCER NEEDLE
In Commercial Distribution

  • 38033055145443 ()
  • 08033055145442 ()
  • 48033055145440 ()

  • Length: 150 Millimeter
IN 16150N

  • Interventional radiology percutaneous-access kit, single-use
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