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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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Diaper and Specimen Scale 10x0.005lb (4500x2g) includes ULc approved, 110 VAC adapter
DORAN SCALES, INC.
PC400-10
In Commercial Distribution

  • 00850013361274 ()
PC400-10

  • Medical/surgical procedure scale, electronic
Diaper and Specimen Scale 5x0.002lb (2300x1g) includes ULc approved, 110 VAC adapter
DORAN SCALES, INC.
PC400-05
In Commercial Distribution

  • 00850013361267 ()
PC400-05

  • Medical/surgical procedure scale, electronic
Diaper and Specimen Scale 2x0.0002lb (1000x0.1g)
DORAN SCALES, INC.
PC400-02
In Commercial Distribution

  • 00850013361250 ()
PC400-02

  • Medical/surgical procedure scale, electronic
Wheelchair Scale with Single Ramp, 100x0.1lb (454x0.05kg)
DORAN SCALES, INC.
DS9100
In Commercial Distribution

  • 00850013361175 ()
DS9100

  • Wheelchair-accessible platform scale
Chair Scale 550x0.2lb (250x0.1kg) includes ULc approved, 110 VAC adapter
DORAN SCALES, INC.
DS8150
In Commercial Distribution

  • 00850013361168 ()
DS8150

  • Chair scale, electronic
Wheelchair Scale with Dual Ramp and Mast 800x0.2lb (360x0.1kg) includes ULc approved, 110 VAC adapter
DORAN SCALES, INC.
DS8030
In Commercial Distribution

  • 00850013361151 ()
DS8030

  • Wheelchair-accessible platform scale
Single Handrail Scale, 1000x0.1lb (454x0.05kg)
DORAN SCALES, INC.
DS7200
In Commercial Distribution

  • 00850013361144 ()
DS7200

  • Stand-on floor scale, electronic
Handrail Scale, 1000x0.1lb (454x0.05kg)
DORAN SCALES, INC.
DS7100
In Commercial Distribution

  • 00850013361137 ()
DS7100

  • Stand-on floor scale, electronic
Handrail Scale, 800x0.2lb (360x0.2kg) includes ULc approved, 110 VAC adapter
DORAN SCALES, INC.
DS7060
In Commercial Distribution

  • 00850013361120 ()
DS7060

  • Stand-on floor scale, electronic
Remote Indicator Scale 500x0.2lb (225x0.1kg), includes ULc approved, 110 VAC adapter
DORAN SCALES, INC.
DS6150
In Commercial Distribution

  • 00850013361113 ()
DS6150

  • Stand-on floor scale, electronic
Bluetooth Digital Flat Scale 400x0.2lb (180x0.1kg)
DORAN SCALES, INC.
DS610
In Commercial Distribution

  • 00850013361106 ()
DS610

  • Stand-on floor scale, electronic
Digital Physicians Scale with Integrated Height Rod 500x0.1lb (200x0.05kg)
DORAN SCALES, INC.
DS5100
In Commercial Distribution

  • 00850013361090 ()
DS5100

  • Stand-on floor scale, electronic
Digital Baby Lactation Scale, 45lbx0.1oz (20kgx2g) includes ULc approved 100-240 VAC 50/60Hz adapter
DORAN SCALES, INC.
DS4500
In Commercial Distribution

  • 00850013361083 ()
DS4500

  • Infant scale, electronic
Neonatal Scale, 44lbx0.1oz (20kgx2g), includes ULc approved 110-220 VAC adapter
DORAN SCALES, INC.
DS4300
In Commercial Distribution

  • 00850013361076 ()
DS4300

  • Infant scale, electronic
Digital Baby Scale, 45lbx0.2oz (20kgx5g)
DORAN SCALES, INC.
DS4100
In Commercial Distribution

  • 00850013361069 ()
DS4100

  • Infant scale, electronic
Digital Baby Scale, 44lbx0.2oz (20kgx5g) includes ULc approved 110 VAC adapter
DORAN SCALES, INC.
DS4050
In Commercial Distribution

  • 00850013361052 ()
DS4050

  • Infant scale, electronic
Mechanical Physician Scale with Height Rod and Flip Scale for LB and KG units
DORAN SCALES, INC.
DS2100
In Commercial Distribution

  • 00850013361045 ()
DS2100

  • Stand-on floor scale, mechanical
Flat Scale - Electronic, 400 x 0.2 lb
DORAN SCALES, INC.
DS500
In Commercial Distribution

  • 00850013361007 ()
DS500

  • Stand-on floor scale, electronic
HMD Custom Lens Insert
Sentiar, Inc.
RXL01
In Commercial Distribution

  • 00850013331079 ()


  • Radiology picture archiving and communication system workstation
HMD
Sentiar, Inc.
HMD02
In Commercial Distribution

  • 00850013331048 ()


  • Radiology picture archiving and communication system workstation
HMD
Sentiar, Inc.
HMD01
In Commercial Distribution

  • 00850013331031 ()


  • Radiology picture archiving and communication system workstation
Enclosure
Sentiar, Inc.
ENC01
In Commercial Distribution

  • 00850013331024 ()


  • Radiology picture archiving and communication system workstation
Data Manager PC
Sentiar, Inc.
DPC01
In Commercial Distribution

  • 00850013331017 ()


  • Radiology picture archiving and communication system workstation
Data Manager PC
Sentiar, Inc.
DPC02
In Commercial Distribution

  • 00850013331000 ()


  • Radiology picture archiving and communication system workstation
IntiMD 8.5 fl oz Water Based Bottle
WESTRIDGE LABORATORIES INCORPORATED
IntiMD 8.5 fl oz Water Based Bottle
In Commercial Distribution

  • 30850013300007 ()
  • 00850013300006 ()
IDD11377

  • Sexual lubricant
IRRAflow Catheter 2.0+ intended for use with the IRRAflow Active Fluid Exchange System
Irras USA, Inc.
ICAT 030
In Commercial Distribution

  • 00850013266258 ()


  • Intracerebral infusion/drainage catheter, short-term
IC42 Cranial Access Kit
Irras USA, Inc.
CK 42
Not in Commercial Distribution

  • 10850013266248 ()
  • 00850013266241 ()


  • Intracerebral catheter cranial-fixation kit
IC 40 Cranial Access Kit
Irras USA, Inc.
CK 40
Not in Commercial Distribution

  • 10850013266231 ()
  • 00850013266234 ()


  • Intracerebral catheter cranial-fixation kit
No Description
Irras USA, Inc.
IC42
In Commercial Distribution

  • 00850013266227 ()
  • 10850013266224 ()


  • Intracerebral catheter cranial-fixation kit
No Description
Irras USA, Inc.
ICDS 030
In Commercial Distribution

  • 10850013266200 ()
  • 00850013266203 ()
  • 00850013266265 ()
ICDS 030

  • Cerebrospinal fluid pressure regulation system, gravity-flow
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