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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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Edwards SAPIEN 3 Ultra Transcatheter Heart Valve - 00690103201321

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Edwards Lifesciences LLC
9750TFX23
In Commercial Distribution

  • 00690103201321 ()

  • Outer Diameter, 23 MM
9750TFX23A

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
  • Basic crimper
  • Catheter/overtube balloon inflator, single-use

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve - 00690103201314

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Edwards Lifesciences LLC
9750TFX20
In Commercial Distribution

  • 00690103201314 ()

  • Outer Diameter, 20 MM
9750TFX20A

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
  • Basic crimper
  • Catheter/overtube balloon inflator, single-use

UREA - 05055273206975

This product is intended for the quantitative in vitro determination of Urea in serum, plasma or urine.
RANDOX LABORATORIES LIMITED
UR9729
In Commercial Distribution

  • 05055273206975 ()
UR9729

  • Urea IVD, reagent

N/A - 20885403473170

Surgical Clipper
CAREFUSION 2200, INC
5513E
In Commercial Distribution

  • 20885403473170 ()
  • 50885403473171 ()
5513E

  • Surgical hair clippers

Spectrum IQ - 00085412610900

The Spectrum IQ Infusion System with Dose IQ Safety Software is an infusion pump that provides delivery of fluids into a patient in a controlled manner. The pumping mechanism is of linear peristaltic design and uses inlet and outlet valves for flow control. The Spectrum IQ infusion pump is specifically manufactured and calibrated for use with Baxter administration sets.
BAXTER INTERNATIONAL INC.
3570009
In Commercial Distribution

  • 00085412610900 ()
3570009

  • Bedside infusion pump, single-channel

SANDBAG 10 LB 10" X 11" SOLD AS A PAIR - 00733657240825

No Description
ALIMED, INC.
936957
In Commercial Distribution

  • 00733657240825 ()
2970014632

  • Traction weight

ADVIA Centaur® EHIV - 00630414511245

HIV 1/O/2 Enhanced (EHIV) (1-pack) 200T Assay Kit
Siemens Healthcare Diagnostics Inc.
10332613
In Commercial Distribution

  • 00630414511245 ()
1622429

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay

Montgomery® Safe-T-Tube™ Plug/Ring Set - 14063107102889

Tracheal T-Tube, 10 mm
Boston Medical Products, Inc.
361106
In Commercial Distribution

  • 14063107102889 ()

  • Fits Size 10 mm Montgomery® Safe-T-Tubes™
361106

  • Tracheostomy tube decannulation cap

Moore Tube Low-Profile Inner Cannula - 14063107102827

Size: 10; Type: Radiopaque
Boston Medical Products, Inc.
MTT-010-LP
In Commercial Distribution

  • 34063107102821 ()
  • 14063107102827 ()

  • Size: 10
MTT-010-LP

  • Tracheostomy tube cannula, reusable

Moore Tube 15 mm Inner Cannula - 14063107102810

Size: 10; Type: Radiopaque
Boston Medical Products, Inc.
MTT-010-CN
In Commercial Distribution

  • 34063107102814 ()
  • 14063107102810 ()

  • Size: 10
MTT-010-CN

  • Tracheostomy tube cannula, reusable
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