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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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Philips Compatible SpO2 Sensor, Adult soft, 6 ft
APK Technology Co.,Ltd.
10588
In Commercial Distribution

  • 06946725548929 ()


  • Pulse Co-oximeter probe, reusable
2.5” Stainless steel Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, Non-sterile, 200 pcs per bulk pack
BIOPROTECH INC.
PEN31NS
In Commercial Distribution

  • 00851255007067 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
The IOLMaster is intended for the biometric determination of ocular measurements for axial length, anterior chamber depth, corneal radius, white-to-white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation.
Carl Zeiss Meditec AG
IOLMaster 500
In Commercial Distribution

  • 04049471092066 ()

  • Weight: 18 Kilogram
  • Height: max. 610 mm (2ft) (head rest)
  • Dimensions (footprint): 390 mm x 300 mm (1.28 ft x 0.98 ft)


  • Optical low coherence reflectometry (OLCR) biometer
Slim, Rocker, 2.5” Non-stick Ceramic or FEP Coated Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, Blister package
BIOPROTECH INC.
PEN41
In Commercial Distribution

  • 20851255007115 ()
  • 00851255007111 ()
  • 10851255007118 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Slim, Button, 2.5” Non-stick Ceramic or FEP Coated Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, Blister package
BIOPROTECH INC.
PEN21
In Commercial Distribution

  • 20851255007108 ()
  • 00851255007104 ()
  • 10851255007101 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
2.5” Stainless steel Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, Blister, Non-sterile, 200 pcs per bulk pack
BIOPROTECH INC.
PEN11NS
In Commercial Distribution

  • 00851255007050 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
The device is a Pre-curved Extraction Kit of ALN Vena Cava Filter including a puncture needle, a J guidewire, a 9F introduction sheath, a dilatator and a pincer catheter 7F.
A.L.N.
FT.902010/VS2
In Commercial Distribution

  • 03760017680110 ()


  • Vena cava filter extraction/repositioning kit
Orthopedic Yankauer Kit, Straight, US
Conmed Corporation
0035001
Not in Commercial Distribution

  • 30653405986304 ()
  • 20653405986307 ()
  • 00653405986303 ()

  • 11/32 IN. (9MM) X 12 FT. (3.7 M)
0035001

  • Surgical/emergency suction cannula, non-illuminating, single-use
Platform lift, 14 ft, Standard, residential, hoistway, battery, outdoor
Harmar Summit, LLC
Highlander II
In Commercial Distribution

  • 00817650024382 ()
VPL1400SRWDCO

  • Wheelchair/occupant lift
Platform lift, 10 ft, Standard, residential, hoistway, battery, indoor
Harmar Summit, LLC
Highlander II
In Commercial Distribution

  • 00817650024214 ()
VPL1000SRWDCI

  • Wheelchair/occupant lift
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