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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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Cube Pessary is used treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Pessary Cube w/drain # 5
In Commercial Distribution

  • M803050071 ()
050071

  • Pelvic-organ-supporting pessary
Pessary ring is used to treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Pessary Ring w/support #5
In Commercial Distribution

  • M803050030 ()
050030

  • Pelvic-organ-supporting pessary
No Description
Izi Medical Products, LLC
PM8005-7D
In Commercial Distribution

  • 00815212026652 ()


  • Radiographic image marker, manual
No Description
SCIMEDX CORPORATION
1005
In Commercial Distribution

  • 00813545020026 ()
1005

  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
No Description
Manus Medical, LLC
AVID334
In Commercial Distribution

  • 20811870033869 ()
  • 00811870033865 ()


  • Surgical towel
ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A5-055
Not in Commercial Distribution

  • B090A50552 ()
  • B090A50551 ()
  • B090A50550 ()
A5-055

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter
No Description
Sonova AG
(silver gray)
In Commercial Distribution

  • 07613389633665 ()
050-1069-P667

  • Air-conduction hearing aid, behind-the-ear
No Description
Sonova AG
(sand beige)
In Commercial Distribution

  • 07613389632026 ()
050-1069-P167

  • Air-conduction hearing aid, behind-the-ear
GSD RPR Microtiterplate - 5 pack sleeve
Gold Standard Diagnostics Corporation
GSD05-1600-W
In Commercial Distribution

  • B350GSD051600W0 ()
GSD05-1600-W

  • Assay container IVD, single-use
  • Treponema pallidum reagin antibody IVD, kit, agglutination
No Description
Izi Medical Products, LLC
02146-001
In Commercial Distribution

  • 00815212024504 ()


  • Radiographic image marker, manual
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