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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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BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 1900ml, Gas Filter
DATASCOPE CORP.
BEQ-TOP 27700
Not in Commercial Distribution

  • 00607567211360 ()
701054389R02

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 30000-USA Pediatric Quadrox iD, Pediatric Temp Probe.
DATASCOPE CORP.
BEQ-TOP 8070
In Commercial Distribution

  • 00607567209565 ()
709000300

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 70000-USA Adult Quadrox iD Softshell Venous Reser. 1900ml w. connector 700000292 Blood Transfer Bag 1000 ml - 2 spike ports RF32 RotaFlow - uncoated Gas Filter
DATASCOPE CORP.
BEQ-TOP 29405
Not in Commercial Distribution

  • 00607567208414 ()
709000153

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, BEQ-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BEQ-TOP 1601
Not in Commercial Distribution

  • 00607567201828 ()
701052285

  • Cardiopulmonary bypass system blood tubing set
A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens.
Alere Scarborough, Inc.
435-000
In Commercial Distribution

  • 10811877010521 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
TEC COM GmbH, Gesellschaft für Technik, Technologie und Vermarktung
TECOTHERM NEO
In Commercial Distribution

  • 04260498580002 ()


  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Trial Size. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 65-12
In Commercial Distribution

  • D801ID6512I1 ()
65-12

  • Dentine adhesive
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-211
In Commercial Distribution

  • D801ID50211I1 ()
50-211

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A3 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-210
In Commercial Distribution

  • D801ID50210I1 ()
50-210

  • Dental composite resin
Self-Cured Resin for Sealing Occusal Fissures and Bonding Composite Restoratives to Etched Enamel. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-12
In Commercial Distribution

  • D801ID5012I1 ()
50-12

  • Dental composite resin
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