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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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The Universal Legholder is contoured and padded for comfortable leg support, and is mounted on a ball joint for positioning flexibility.
STERIS CORPORATION
BF266
In Commercial Distribution

  • 00724995156985 ()
BF266

  • Leg procedure positioner
The TriNEST™ microplate incubator and shaker is intended for use in laboratories where incubation and shaking of microplates is needed.
Wallac Oy
1296-0050
In Commercial Distribution

  • 06438147297726 ()
1296-0050

  • Laboratory shaker IVD
Case/Carton of 425 boxes of 50 TEST STRIPS HEPRO.US MM1000 - the FDA number is 3012098689 - the operator number is 10049962
HEPRO.US INC.
Hepro.usTSC
In Commercial Distribution

  • 00850578007389 ()
  • 85057800738902 ()


  • Glucose monitoring system IVD, home-use
The material is an alternative to traditional dental prostheses material. SprintRay OnX Tough resin is intended exclusively for professional dental work.
Sprintray, Inc.
SRI-0202120
In Commercial Distribution

  • 00850039704536 ()

  • Weight: 1 Kilogram
SRI-0202120

  • Dental appliance fabrication material, resin
The material is an alternative to traditional dental prostheses material. SprintRay OnX Tough resin is intended exclusively for professional dental work.
Sprintray, Inc.
SRI-0202119
In Commercial Distribution

  • 00850039704529 ()

  • Weight: 1 Kilogram
SRI-0202119

  • Dental appliance fabrication material, resin
The material is an alternative to traditional dental prostheses material. SprintRay OnX Tough resin is intended exclusively for professional dental work.
Sprintray, Inc.
SRI-0202118
In Commercial Distribution

  • 00850039704512 ()

  • Weight: 1 Kilogram
SRI-0202118

  • Dental appliance fabrication material, resin
The material is an alternative to traditional dental prostheses material. SprintRay OnX Tough resin is intended exclusively for professional dental work.
Sprintray, Inc.
SRI-0202071
In Commercial Distribution

  • 10850039704175 ()
  • 00850039704178 ()

  • Total Volume: 1 Liter
SRI-0202071

  • Dental appliance fabrication material, resin
The material is an alternative to traditional dental prostheses material. SprintRay NightGuard Firm resin is intended exclusively for professional dental work.
Sprintray, Inc.
SRI-0202016
In Commercial Distribution

  • 10850039704168 ()
  • 00850039704161 ()

  • Total Volume: 1 Liter
SRI-0202016

  • Dental appliance fabrication material, resin
The Zap-X Radiosurgery System (“Zap-X System”) is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.
ZAP SURGICAL SYSTEMS, INC.
300150
In Commercial Distribution

  • 00860183001504 ()


  • Stereotactic radiosurgery/radiation therapy linear accelerator system
Capture-P solid phase system is intended for use in the detection of antibodies to platelets. This is the single microplate product.
IMMUCOR, INC.
0066246
In Commercial Distribution

  • 10888234001270 ()
0066246

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination
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