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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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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
No Description
Changzhou Care-de Sanitary Material Co.,Ltd.
21”*225 ft
In Commercial Distribution

  • 06976289698013 ()


  • Examination/treatment table paper
No Description
Changzhou Hongtai Paper Film Co.,Ltd.
21”*225 ft
In Commercial Distribution

  • 06972952008011 ()


  • Examination/treatment table paper
TITAN Curette "Langer Standard" # 5-6 Grade 4 F-LINE | SL | double ended
devemed GmbH
LAM 05-06 FT
In Commercial Distribution

  • 04061644024483 ()


  • Bone curette, reusable
TITAN Curette "Langer Standard" # 3-4 Grade 4 F-LINE | SL | double ended
devemed GmbH
LAM 03-04 FT
In Commercial Distribution

  • 04061644024476 ()


  • Bone curette, reusable
TITAN Curette "Langer Standard" # 1-2 Grade 4 F-LINE | SL | double ended
devemed GmbH
LAM 01-02 FT
In Commercial Distribution

  • 04061644024469 ()


  • Bone curette, reusable
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