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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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Sterrad - 10705037043163

Holder 5 mm x 5 mm x 5 mm
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
99406
In Commercial Distribution

  • 20705037043160 ()
  • 10705037043163 ()
99406

  • Instrument tray, reusable

Flowflex COVID-19 Antigen Home Test - 00682607660285

Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5)
Acon Laboratories, Inc.
L031-125N5
In Commercial Distribution

  • 20682607660289 ()
  • 00682607660285 ()
  • 00682607002306 ()
660285

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

COM module for use with the MAC 5500 ST electrocardiograph - 04059358001470

No Description
ergoline GmbH
705780
In Commercial Distribution

  • 04059358001470 ()


  • Bicycle ergometer

VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container, com - 07640172552438

VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container, complete
icotec AG
42-700
In Commercial Distribution

  • 07640172552438 ()
42-700

  • Device sterilization/disinfection container, reusable

ParaPost Taper Lux - D661PF18151

5 ParaPost TaperLux Posts, Size 5
COLTENE/WHALEDENT INC
PF1815
In Commercial Distribution

  • D661PF18151 ()
  • D661PF18150 ()
  • 00840016201745 ()


  • Root canal post, preformed

ParaPost Fiber Lux - D661PF17151

5 ParaPost FiberLux Posts, Size 5
COLTENE/WHALEDENT INC
PF1715
In Commercial Distribution

  • D661PF17151 ()
  • D661PF17150 ()
  • 00840016201707 ()


  • Root canal post, preformed

Cytal® - 00386190001011

Burn Matrix 5 X 5 cm
ACELL, INC.
BMM0505
Not in Commercial Distribution

  • 00386190001011 ()

  • Rectangle device approximately 5 x 5 cm
BMM0505

  • Animal-derived wound matrix dressing

MatriStem - 00386190000403

Surgical Matrix 5 x 5 cm
ACELL, INC.
PSMX0505
Not in Commercial Distribution

  • 00386190000403 ()

  • Rectangle device approximately 5 x 5 cm
PSMX0505

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

Phospholin ES w/Calcium - 10859394006238

APTT reagent 5 x 5 ml
R 2 DIAGNOSTICS, INC.
21-405
In Commercial Distribution

  • 10859394006238 ()
  • 00859394006231 ()
21-405

  • Activated partial thromboplastin time (APTT) IVD, reagent

gSource - 00840314210135

Bunge Evisceration Spoon 5", #5, 12.0mm
GSOURCE LLC
gS 27.7712
In Commercial Distribution

  • 00840314210135 ()
gS 27.7712

  • Lens spoon
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