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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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PC 400 J-Soft, 60cm
PENUMBRA, INC.
4004J60-A
In Commercial Distribution

  • 00815948020313 ()
4004J60

  • Embolization implant kit
PC 400 J-Soft, 50cm
PENUMBRA, INC.
4004J50-A
In Commercial Distribution

  • 00815948020306 ()
4004J50

  • Embolization implant kit
PC 400 J-Soft, 45cm
PENUMBRA, INC.
4004J45-A
In Commercial Distribution

  • 00815948020290 ()
4004J45

  • Embolization implant kit
PC 400 J-Soft, 40cm
PENUMBRA, INC.
4004J40-A
In Commercial Distribution

  • 00815948020283 ()
4004J40

  • Embolization implant kit
PC 400 J-Soft, 35cm
PENUMBRA, INC.
4004J35-A
In Commercial Distribution

  • 00815948020276 ()
4004J35

  • Embolization implant kit
Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
LIN-ZHI INTERNATIONAL, INC.
0221
In Commercial Distribution

  • B07602210 ()
0221

  • Ethanol (ETOH) IVD, kit, enzyme spectrophotometry
Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
LIN-ZHI INTERNATIONAL, INC.
0220
In Commercial Distribution

  • B07602200 ()
0220

  • Ethanol (ETOH) IVD, kit, enzyme spectrophotometry
RemLogic 4.0 Software (English)
Embla Systems Ltd
025406
In Commercial Distribution

  • 00382830048484 ()


  • Sleep disorder interpretive software
STRAPS, LEG BAG, ELASTIC, HOOK&LOOP, PR
MEDLINE INDUSTRIES, INC.
DYND12582
In Commercial Distribution

  • 30888277101559 ()
  • 10888277101555 ()
DYND12582

  • Open-ended wearable urine collection bag, non-sterile
No Description
Roche Diagnostics GmbH
3183777190
In Commercial Distribution

  • 04015630918959 ()
3183777190

  • Ethanol (ETOH) IVD, kit, enzyme spectrophotometry
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