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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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Inogen One G4 Oxygen Concentrator - Bluetooth (10-08300-00-01)
Inogen, Inc.
630 Bluetooth
In Commercial Distribution

  • 00817131020179 ()
IO-400

  • Mobile/portable oxygen concentrator
Inogen One G5 Oxygen Concentrator - Bluetooth (10-08123-XX-XX)
Inogen, Inc.
1260 Bluetooth
In Commercial Distribution

  • 00817131020162 ()
IO-500

  • Mobile/portable oxygen concentrator
Trials 11x14mm 7° w/one sided stop-10mm
Nuvasive, Inc.
Z700157-10
In Commercial Distribution

  • 00887517950291 ()


  • Spinal implant trial
Alpha Reline One MAS Reduction Imp Tray
Nuvasive, Inc.
ALPRELONEMASRED
In Commercial Distribution

  • 00195377050212 ()


  • Internal spinal fixation procedure kit, reusable
MOBILE ANEROID W ONE PIECE CUFF MX
WELCH ALLYN, INC.
901091
In Commercial Distribution

  • 00732094342000 ()
420229

  • Aneroid manual sphygmomanometer
Visualase Anchor Bolt Driver Guide for ROSA ONE (1) Anchor Bolt Driver Guide for ROSA ONE Brain
FHC, INC.
9736542-00913
In Commercial Distribution

  • 00873263009130 ()
9736542

  • Neurological stereotactic surgery system
Coldpac Denture and Repair Acrylic Kit. Contains one 16 oz. powder (Clear) and one 8 oz. liquid.
BIRD-X, INC.
DK1608
In Commercial Distribution

  • 00706069343866 ()

  • Weight: 1 Pound
  • Total Volume: 8.0 Fluid Ounce


  • Dental appliance fabrication material, resin
Coldpac Denture and Repair Acrylic Kit. Contains one 16 oz. powder (Granular) and one 8 oz. liquid.
BIRD-X, INC.
DK1607
In Commercial Distribution

  • 00706069343767 ()

  • Total Volume: 8.0 Fluid Ounce
  • Weight: 1 Pound


  • Dental appliance fabrication material, resin
Integra® Jarit® Pomeroy Ear Syringe, With One Tapered Tip And One Bulbous Tip 4 oz
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
380362
In Commercial Distribution

  • M2743803621 ()
  • 10381780198215 ()
380-362

  • Ear canal irrigation syringe
Integra® Jarit® Pomeroy Ear Syringe, With One Tapered Tip And One Bulbous Tip 2 oz
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
380360
In Commercial Distribution

  • M2743803601 ()
  • 10381780198208 ()
380-360

  • Ear canal irrigation syringe
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