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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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Peripheral quantitative computed tomograph for the measurement at femur, radius or tibia. Evaluation of volumetric bone density, bone geometry and muscle parameter at the forarm, upper or lower leg using peripheral quantitative computes tomography.
Stratec Medizintechnik GmbH
XCT 3000
In Commercial Distribution

  • 04260491560025 ()
XCT 3000

  • Limited-view-field CT system
Peripheral quantitative computed tomograph for the measurement at femur, radius or tibia. Evaluation of volumetric bone density, bone geometry and muscle parameter at the forarm, upper or lower leg using peripheral quantitative computes tomography.
Stratec Medizintechnik GmbH
XCT 2000L
In Commercial Distribution

  • 04260491560018 ()
XCT 2000L

  • Limited-view-field CT system
Gimbel-Mendez Beveled Degree Gauge with teeth, 5 Degree Ruler markings on top of Unique bevel (labeled at 30 Degree increments), Mounted at 90 Degrees, Round Knurled Handle, 117mm Overall Length, Titanium (with Stainless color)
Crestpoint Management Limited
PH94071T
Not in Commercial Distribution

  • G412PH94701T0 ()


  • Medical ruler, reusable
Gimbel-Mendez Beveled Degree Gauge with teeth, 5 Degree Ruler markings on top of Unique bevel (labeled at 30 Degree increments), Mounted at 90 Degrees, Round Knurled Handle, 117mm Overall Length, Titanium (with Stainless color)
Crestpoint Management Limited
PH94071T
In Commercial Distribution

  • G412PH94071T0 ()


  • Medical ruler, reusable
Liquid Urine Control Dipstick - Negative/Positive, 20 ml. Contains 3 vials Negative and 3 vials Positive. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
301-12
In Commercial Distribution

  • 30858512007021 ()

  • Total Volume: 20 Milliliter
301-12

  • Multiple urine analyte IVD, control
The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.
Shenzhen AOJ Medical Technology Co., Ltd
AOJ-35D
In Commercial Distribution

  • 06972040110794 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
5mm 45cm Endoclinch Fenestrated Grasper, 30deg angled shaft at distal end, designed for Single Site Trocars (Bend Begins at 12cm from Distal Tip), 3-piece modular take-apart, type 6 handle: lightweight carbon-fiber with RF post & ratchet
Avalign Technologies, Inc.
72-5215527C6SST
In Commercial Distribution

  • 00190776297503 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
Crestpoint Mr. Phaco Mackool Maxicurve Big Ball Chopper (horizontal) DBL-Ended 0.6mm Mackool ball shaped tip with C-shaped curved shaft, Angled 10mm at 45* / Cylindrical Spatula, slightly vaulted 11.5mm at 50*, short round knurled handle, Titanium
Crestpoint Management Limited
PH6004T
In Commercial Distribution

  • G412PH6004T0 ()


  • Soft-tissue surgical hook, reusable
A battery charger for the battery pack. Three packs can be charged at the same time.
FUJIFILM CORPORATION
DR601 SE BATTERY CHARGER E
In Commercial Distribution

  • 04547410180220 ()


  • Stationary basic diagnostic x-ray system, digital
To be attached at the tube saw to provide the required torque to saw the bone.
OSTEOTEC LIMITED
OST-CBG-15
In Commercial Distribution

  • 05060183095694 ()
OST-CBG-15

  • Surgical instrument handle, non-torque-limiting
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