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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G50, MINIRITE T 312 2.4G C092 REVEAL
Oticon A/S
177294
In Commercial Distribution

  • 05711584072356 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G300, MINIRITE T 312 2.4G C063 AGXO
Oticon A/S
177249
In Commercial Distribution

  • 05711584071892 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G300, MINIRITE T 312 2.4G C044 AGXO
Oticon A/S
177247
In Commercial Distribution

  • 05711584071878 ()


  • Air-conduction hearing aid, receiver-in-the-ear
Amigo RT Express
AMIGO MOBILITY INTERNATIONAL, INC.
RT Express
In Commercial Distribution

  • 00863048000315 ()


  • Assistive scooter, electric-motor-driven
G300, MINIRITE T 312 2.4G C091 AGXO
Oticon A/S
177245
In Commercial Distribution

  • 05711584071854 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G300, MINIRITE T 312 2.4G C090 AGXO
Oticon A/S
177243
In Commercial Distribution

  • 05711584071830 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G400, MINIRITE T 312 2.4G C094 AGXO
Oticon A/S
177241
In Commercial Distribution

  • 05711584071816 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G400, MINIRITE T 312 2.4G C090 AGXO
Oticon A/S
177236
In Commercial Distribution

  • 05711584071762 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G500, MINIRITE T 312 2.4G C044 AGXO
Oticon A/S
177233
In Commercial Distribution

  • 05711584071731 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G500, MINIRITE T 312 2.4G C091 AGXO
Oticon A/S
177231
In Commercial Distribution

  • 05711584071717 ()


  • Air-conduction hearing aid, receiver-in-the-ear
The P2131-3 Sterilizer Water Softener (SWS) is the component that filters and de-mineralizes the incoming water to prevent scale build-up in the P2131 Automated Field Sterilizer system. The P2131 is an automated, pre- and post-vacuum steam sterilizer designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for field use in a variety of austere environments. The P2131 sterilizer consists of three components that work together as one integrated system. These components are the (1) Sterilizer Main Unit (SMU), (2) Water Recovery System (WRS), and (3) the Sterilizer Water Softener (SWS).
FORT DEFIANCE INDUSTRIES, LLC
P2131-3
In Commercial Distribution

  • 00862992000334 ()

  • Weight: 50 Pound
  • Height: 34 Inch
  • Width: 13 Inch
  • Length: 20 Inch


  • Steam sterilizer
G500, MINIRITE T 312 2.4G C090 AGXO
Oticon A/S
177229
In Commercial Distribution

  • 05711584071694 ()


  • Air-conduction hearing aid, receiver-in-the-ear
The P2131-1 Sterilizer Main Unit (SMU) is the sterilizer component of the P2131 Automated Field Sterilizer system. The P2131 is an automated, pre- and post-vacuum steam sterilizer designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for field use in a variety of austere environments. The P2131 sterilizer consists of three components that work together as one integrated system. These components are the (1) Sterilizer Main Unit (SMU), (2) Water Recovery System (WRS), and (3) the Sterilizer Water Softener (SWS).
FORT DEFIANCE INDUSTRIES, LLC
P2131-1
In Commercial Distribution

  • 00862992000310 ()

  • Weight: 295 Pound
  • Height: 62 Inch
  • Width: 26.75 Inch
  • Length: 38 Inch


  • Steam sterilizer
G400, MINIRITE T 312 2.4G C063 HHM
Oticon A/S
177227
In Commercial Distribution

  • 05711584071670 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G500, MINIRITE T 312 2.4G C063 HHM
Oticon A/S
177226
In Commercial Distribution

  • 05711584071663 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G300, MINIRITE T 312 2.4G C094 HHM
Oticon A/S
177217
In Commercial Distribution

  • 05711584071625 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G300, MINIRITE T 312 2.4G C093 HHM
Oticon A/S
177215
In Commercial Distribution

  • 05711584071601 ()


  • Air-conduction hearing aid, receiver-in-the-ear
Decipher Holter Monitor is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM461
Not in Commercial Distribution

  • 00862887000364 ()


  • Electrocardiographic ambulatory recorder
G300, MINIRITE T 312 2.4G C092 HHM
Oticon A/S
177213
In Commercial Distribution

  • 05711584071588 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G300, MINIRITE T 312 2.4G C090 HHM
Oticon A/S
177212
In Commercial Distribution

  • 05711584071571 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G400, MINIRITE T 312 2.4G C094 HHM
Oticon A/S
177211
In Commercial Distribution

  • 05711584071564 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G400, MINIRITE T 312 2.4G C093 HHM
Oticon A/S
177209
In Commercial Distribution

  • 05711584071540 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G400, MINIRITE T 312 2.4G C092 HHM
Oticon A/S
177207
In Commercial Distribution

  • 05711584071526 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G400, MINIRITE T 312 2.4G C090 HHM
Oticon A/S
177206
In Commercial Distribution

  • 05711584071519 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G500, MINIRITE T 312 2.4G C044 HHM
Oticon A/S
177204
In Commercial Distribution

  • 05711584071496 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G500, MINIRITE T 312 2.4G C093 HHM
Oticon A/S
177203
In Commercial Distribution

  • 05711584071489 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G500, MINIRITE T 312 2.4G C091 HHM
Oticon A/S
177202
In Commercial Distribution

  • 05711584071472 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G500, MINIRITE T 312 2.4G C092 HHM
Oticon A/S
177201
In Commercial Distribution

  • 05711584071465 ()


  • Air-conduction hearing aid, receiver-in-the-ear
G500, MINIRITE T 312 2.4G C090 HHM
Oticon A/S
177200
In Commercial Distribution

  • 05711584071458 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR9 MNR, 2.4G NFM PB SABE/MAC DEMO ZERENA 9
Bernafon AG
177139
In Commercial Distribution

  • 05711584070987 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR5 MNR, 2.4G NFM PB JEBL ZERENA 5
Bernafon AG
177137
In Commercial Distribution

  • 05711584070963 ()


  • Air-conduction hearing aid, receiver-in-the-ear
Fiber Optic Medical Light Carrier
FIBEROPTICS TECHNOLOGY, INC.
Fiber Optic Medical Light Guide
In Commercial Distribution

  • 00862658000319 ()


  • Operating room light
LO-50 LED Fiber Optic Light Source
FIBEROPTICS TECHNOLOGY, INC.
LO-50
In Commercial Distribution

  • 00862658000302 ()


  • Operating room light
Blood Transfer Device
WESTCLIFF MEDICAL PRODUCTS
WC6018
In Commercial Distribution

  • 00862572000358 ()
  • 10862572000355 ()
  • 20862572000352 ()


  • Blood collection tube holder, single-use
No Description
LAURIMED, LLC
4.0mm Microdebrider
In Commercial Distribution

  • 00862519000328 ()
  • 00862519000335 ()
FG-000017

  • ENT shaver system handpiece
No Description
LAURIMED, LLC
3.3mm Microdebrider
In Commercial Distribution

  • 00862519000304 ()
  • 00862519000311 ()
FG-000016

  • ENT shaver system handpiece
Topical hemostatic pad
Chitogen Inc
2160
In Commercial Distribution

  • 10862499000261 ()
  • 00862499000264 ()

  • Length: 1.25 Inch
  • Width: 1.25 Inch


  • Wound-nonadherent dressing, permeable, non-antimicrobial
hemostatic dressing
Chitogen Inc
2010
In Commercial Distribution

  • 10862499000254 ()
  • 00862499000257 ()

  • Length: 1 Inch
  • Width: 1 Inch


  • Wound-nonadherent dressing, permeable, non-antimicrobial
Topical hemostatic pad
Chitogen Inc
2150
In Commercial Distribution

  • 00862499000202 ()
  • 10862499000209 ()

  • Length: 2 Inch
  • Width: 2 Inch


  • Wound-nonadherent dressing, permeable, non-antimicrobial
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
NUSMILE, LTD.
NMTA 7.0
Not in Commercial Distribution

  • 00862487000320 ()

  • Weight: 7.0 Gram
None

  • Glass ionomer dental cement
  • Endodontic filling/sealing material
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