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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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No Description
ACCUTRON, INC.
34062-9
In Commercial Distribution

  • 00813830021882 ()
34062-9

  • Medical gas pipeline system
No Description
ACCUTRON, INC.
34061-9
In Commercial Distribution

  • 00813830021868 ()
34061-9

  • Medical gas pipeline system
No Description
Sonova AG
9.1
In Commercial Distribution

  • 07613389709483 ()
058-0125-091

  • Audiometric/hearing device software
ContrIL 9 Level 3
INSTRUMENTATION LABORATORY COMPANY
00024001421
In Commercial Distribution

  • 08426950087915 ()
  • 18426950087912 ()
00024001421

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
ContrIL 9 Level 2
INSTRUMENTATION LABORATORY COMPANY
00024001420
In Commercial Distribution

  • 08426950087908 ()
  • 18426950087905 ()
00024001420

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
ContrIL 9 Level 1
INSTRUMENTATION LABORATORY COMPANY
00024001419
In Commercial Distribution

  • 08426950087892 ()
  • 18426950087899 ()
00024001419

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FRP 935
In Commercial Distribution

  • 00840118103602 ()

  • Height: 3.7 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FRP 909
In Commercial Distribution

  • 00840118103510 ()

  • Height: 3.2 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FRP 709
In Commercial Distribution

  • 00840118103411 ()

  • Height: 2.5 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00109
In Commercial Distribution

  • 10858395006513 ()
  • 00858395006516 ()
GW-MOL-SP09

  • Dental delivery system instrument unit, electric
THC PLUS LEVEL 9
UTAK LABORATORIES, INC.
THC+ 9 U F WCT
In Commercial Distribution

  • B800THC9UFWCT5 ()
  • B800THC9UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 9 U F WCT

  • Multiple-type clinical chemistry analyte profile IVD, control
Coil for G-scan Brio
ESAOTE SPA
131000400
In Commercial Distribution

  • 08056304452870 ()


  • MRI system coil, radio-frequency
No Description
HPF SRL
9095.11.302
In Commercial Distribution

  • 08055727374578 ()


  • Surgical depth gauge, reusable
No Description
HPF SRL
H0010354099
In Commercial Distribution

  • 08055727374561 ()


  • Surgical depth gauge, reusable
No Description
HELENA LABORATORIES CORPORATION
552138
In Commercial Distribution

  • M5255521380 ()


  • Faecal occult blood IVD, kit, rapid colorimetric, clinical
No Description
ZIRKONZAHN SRL
ZRAE0501
In Commercial Distribution

  • D800ZRAE0501 ()


  • Dental bridge, ceramic
Content: 1 piece Height: 16 mm Highly translucent zirconia for single crowns to large bridges (fully anatomic structures or reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAD0501
In Commercial Distribution

  • D800ZRAD0501 ()


  • Dental bridge, ceramic
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
3017
In Commercial Distribution

  • 00842430112775 ()
3017

  • Bed traction frame
40402 Head Rest 9''
XODUS MEDICAL, INC.
40402
In Commercial Distribution

  • 20787551003981 ()
  • 00787551003987 ()
40402

  • Freestanding patient positioner, single-use
Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The Standard model is made for use with or without a voice prosthesis. The Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The standard model can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7607
In Commercial Distribution

  • 07331791002175 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 55 Millimeter
7607

  • Tracheostomy tube, non-reinforced, non-customized, reusable
Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The Standard model is made for use with or without a voice prosthesis. The Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The standard model can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7606
In Commercial Distribution

  • 07331791002151 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 36 Millimeter
7606

  • Tracheostomy tube, non-reinforced, non-customized, reusable
Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The Standard model is made for use with or without a voice prosthesis. The Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The standard model can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7605
In Commercial Distribution

  • 07331791002137 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 27 Millimeter
7605

  • Tracheostomy tube, non-reinforced, non-customized, reusable
No Description
BIOPRO, INC.
17339
In Commercial Distribution

  • M209173390 ()


  • Press-fit hip femur prosthesis, modular
Scan Post 9 mm
BHI IMPLANTS LTD
1
In Commercial Distribution

  • 07290109742953 ()

  • Height: 9.0 Millimeter
BH-SP4509

  • Dental implant suprastructure, temporary, preformed, single-use
No Description
BIOPRO, INC.
19057
In Commercial Distribution

  • M209190570 ()


  • Metal-on-polyethylene total hip prosthesis
No Description
BIOPRO, INC.
19008
In Commercial Distribution

  • M209190080 ()


  • Metal-on-polyethylene total hip prosthesis
No Description
BIOPRO, INC.
10138
In Commercial Distribution

  • M209101380 ()


  • Press-fit hip femur prosthesis, modular
No Description
BIOPRO, INC.
10128
In Commercial Distribution

  • M209101280 ()


  • Press-fit hip femur prosthesis, modular
No Description
BIOPRO, INC.
19135
In Commercial Distribution

  • M209191350 ()


  • Metal-on-polyethylene total hip prosthesis
No Description
BIOPRO, INC.
18592
In Commercial Distribution

  • M209185920 ()


  • Metal-on-polyethylene total hip prosthesis
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