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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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
IC42 Cranial Access Kit
Irras USA, Inc.
IC42
In Commercial Distribution

  • 10850013266194 ()
  • 00850013266197 ()
IC42

  • Intracerebral catheter cranial-fixation kit
IC42-D Cranial Access Kit (w/ Drugs)
Irras USA, Inc.
IC42-D
Not in Commercial Distribution

  • 10850013266187 ()
  • 00850013266180 ()
IC42-D

  • Intracerebral catheter cranial-fixation kit
Hummingbird® HICP200 Monitor Interconnect Cable - Spacelabs 6 Pin Monitor
Irras USA, Inc.
7000332
In Commercial Distribution

  • 00850013266104 ()
7000332

  • Intracranial pressure monitor
H110 Hummingbird Parenchymal Catheter Tray
Irras USA, Inc.
H110
In Commercial Distribution

  • 10850013266033 ()
  • 00850013266036 ()

  • Catheter Gauge: 6 French
H110

  • Intracerebral sensor catheter, short-term
H610 Hummingbird SynergyDuo Ventricular Catheter Tray
Irras USA, Inc.
H610
In Commercial Distribution

  • 10850013266026 ()
  • 00850013266029 ()

  • Catheter Gauge: 8.5 French
H610

  • Intracerebral sensor catheter, short-term
HICP200 Hummingbird Patient / Monitor Interconnect Cable
Irras USA, Inc.
HICP200
In Commercial Distribution

  • 10850013266019 ()
  • 00850013266012 ()
HICP200

  • Intracranial pressure monitor
No Description
Irras USA, Inc.
IC40
In Commercial Distribution

  • 00850013266005 ()
  • 10850013266002 ()
IC40

  • Intracerebral catheter cranial-fixation kit
Molding dummy is used to install the Aria Universal Mini Valve in a prosthesis socket
CYPRESS ADAPTIVE, LLC
CA100-MVD
Not in Commercial Distribution

  • 00850013242894 ()
CA100-MVD

  • External lower-limb prosthesis suspensory component, non-powered
Tool to install or remove valves for prosthesis sockets
CYPRESS ADAPTIVE, LLC
CA100-MVK
In Commercial Distribution

  • 00850013242887 ()


  • External lower-limb prosthesis suspensory component, non-powered
Spare parts/replacement parts - threaded housing metric Aria safety barb
CYPRESS ADAPTIVE, LLC
CA300-SBTHM
In Commercial Distribution

  • 00850013242863 ()
CA300-SBTM

  • External lower-limb prosthesis suspensory component, non-powered
Spare parts/replacement parts - Aria safety barb
CYPRESS ADAPTIVE, LLC
CA300-SBTH
In Commercial Distribution

  • 00850013242856 ()
CA300-SBTH

  • External lower-limb prosthesis suspensory component, non-powered
Spare parts/replacement parts for AK valve.
CYPRESS ADAPTIVE, LLC
CA100-MD
In Commercial Distribution

  • 00850013242849 ()
CA100-MD

  • External lower-limb prosthesis suspensory component, non-powered
Spare parts/replacement parts for Aria valves - duck bill check valve
CYPRESS ADAPTIVE, LLC
CA300-SBIV
In Commercial Distribution

  • 00850013242832 ()
CA300-SBIV

  • External lower-limb prosthesis suspensory component, non-powered
Spare parts/replacement parts for Aria valves
CYPRESS ADAPTIVE, LLC
CA300-O
In Commercial Distribution

  • 00850013242825 ()
CA300-O

  • External lower-limb prosthesis suspensory component, non-powered
Spare parts/replacement parts for Aria AK valves
CYPRESS ADAPTIVE, LLC
CA100-O
In Commercial Distribution

  • 00850013242818 ()
CA100-O

  • External lower-limb prosthesis suspensory component, non-powered
Spare parts/replacement parts for Aria valves
CYPRESS ADAPTIVE, LLC
CA300-RB
In Commercial Distribution

  • 00850013242801 ()
CA300-RB

  • External lower-limb prosthesis suspensory component, non-powered
Spare parts/replacement parts for Aria Plate valves.
CYPRESS ADAPTIVE, LLC
CA300-G
In Commercial Distribution

  • 00850013242795 ()
CA300-G

  • External lower-limb prosthesis suspensory component, non-powered
Spare parts/replacement parts for valves metric Threaded Housing for use with either Aria Valve metric and Aria valve Plus metric
CYPRESS ADAPTIVE, LLC
CA200-THM
In Commercial Distribution

  • 00850013242788 ()
CA200-THM

  • External lower-limb prosthesis suspensory component, non-powered
Spare parts/replacement parts for valves: US Threaded Housing for use with either Aria Valve US and Aria valve Plus US
CYPRESS ADAPTIVE, LLC
CA200-TH
In Commercial Distribution

  • 00850013242771 ()
CA200-TH

  • External lower-limb prosthesis suspensory component, non-powered
Spare parts/replacement parts for Aria valve plus and Aria hybrid valve.
CYPRESS ADAPTIVE, LLC
CA200-AVPS
In Commercial Distribution

  • 00850013242764 ()
CA200AVPS

  • External lower-limb prosthesis suspensory component, non-powered
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