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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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Sebacia Microparticles ia a medical device consisting of engineered gold microparticles suspension intended for single use topical application. Sebacia Microparticles are designed to work as an accessory to a commercially available medically approved 1064nm laser by preferentially absorbing the light and converting it to heat, creating a focal thermal effect to the follicle and sebaceous gland for the treatment of acne vulgaris.
SEBACIA, INC.
SEB-250-3P-US
In Commercial Distribution

  • 20850002391019 ()
  • 10850002391111 ()

  • Total Volume: 3 Milliliter
SEB-250-3P-US

  • Photothermal therapy gel
No Description
DIAGNOSTICA STAGO
00595
In Commercial Distribution

  • 13607450005957 ()
  • 03607450005950 ()


  • Activated partial thromboplastin time (APTT) IVD, kit, clotting
Patient Transportation PTT Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobial Impervious Partially-Fitted Gurney Sheet, 34x66 Disposable Standard Draw Sheet, and STAT-BLOC Disposable Pillowcase.
Bosma Enterprises
10-9030PTT
In Commercial Distribution

  • 10818634020304 ()
  • 00818634020307 ()
10-9030PTT

  • Pillow cover, single-use
  • Basic bed sheet, single-use
Temperature Verification Cartridge
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
J-1001
In Commercial Distribution

  • 10711234540107 ()
J-1001

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Electronic System Verification - Normal
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
JEN-QC
In Commercial Distribution

  • 10711234540084 ()
JEN-QC

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Temperature Verification Tube
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
HR1003
In Commercial Distribution

HR1003

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Protective Sleeves
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
DCJ-005
In Commercial Distribution

  • 10711234540046 ()
DCJ-005

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Data Manager V3.0
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
HRDM3CD
In Commercial Distribution

  • 10711234540022 ()
HRDM3CD

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Hemochron Whole Blood Coagulation System - Hemochron Response Instrument (Demonstration)
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
HRS.110-D
In Commercial Distribution

  • 10711234520062 ()
HRS.110-D

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Hemochron Whole Blood Coagulation System - Hemochron Response Instrument Refurbished
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
HRS.RF
In Commercial Distribution

  • 10711234520048 ()
HRS.RF

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
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