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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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Plenity® - 00860517002672

Super-absorbent hydrogel to aid in weight management. Refill Kit.
GELESIS, INC.
MC0684
In Commercial Distribution

  • 00860517002634 ()
  • 00860517002672 ()


  • Ingested gastric satiety device

Plenity® - 00860517002665

Super-absorbent hydrogel to aid in weight management. Welcome Kit.
GELESIS, INC.
MC0683
In Commercial Distribution

  • 00860517002634 ()
  • 00860517002665 ()


  • Ingested gastric satiety device

extriCARE - 00879766005471

3600 Pump set with one canister in a box
OAKWELL DISTRIBUTION, INC.
EC3600-E
In Commercial Distribution

  • 10879766005478 ()
  • 00879766005471 ()


  • Multi-purpose low-vacuum suction system

extriCARE - 00879766005464

2400 Pump set with a canister in a box
OAKWELL DISTRIBUTION, INC.
EC2400-E
In Commercial Distribution

  • 10879766005461 ()
  • 00879766005464 ()


  • Multi-purpose low-vacuum suction system

ClearChem Diagnostics Inc. Vitamin D (25-OH-D) Set - 00852169008386

In Vitro Diagnostics testing set R1: 1X40mL, R2: 1X10mL
CLEARCHEM DIAGNOSTICS INC.
VTD1200
In Commercial Distribution

  • 00852169008386 ()

  • Total Volume: 50 Milliliter


  • Multiple form 25-hydroxy Vitamin D IVD, reagent

ClearChem Diagnostics Inc. Vitamin D (25-OH-D) Kit - 00852169008379

In Vitro Diagnostics testing kit R1: 1X20mL, R2: 1X5mL
CLEARCHEM DIAGNOSTICS INC.
VTD1100
In Commercial Distribution

  • 00852169008379 ()

  • Total Volume: 25 Milliliter


  • Multiple form 25-hydroxy Vitamin D IVD, reagent

ClearChem Diagnostics Inc. Direct Bilirubin - 00852169008324

In Vitro Diagnostics testing kit R1C: 4X52.5mL, R1B: 4X52.5mL
CLEARCHEM DIAGNOSTICS INC.
BRD210
In Commercial Distribution

  • 00852169008324 ()

  • Total Volume: 420 Milliliter


  • Conjugated (direct) bilirubin IVD, reagent

ClearChem Diagnostics Inc. Total Bilirubin - 00852169008317

In Vitro Diagnostics testing kit R1C: 4X52.5mL, R1B: 4X52.5mL
CLEARCHEM DIAGNOSTICS INC.
BRB212
In Commercial Distribution

  • 00852169008317 ()

  • Total Volume: 420 Milliliter


  • Total bilirubin IVD, reagent

ClearChem Diagnostics Inc. MicroProtein, Total - 00852169008294

In Vitro Diagnostics testing kit R1:4X60mL, STD 1X15mL
CLEARCHEM DIAGNOSTICS INC.
MPN2020
In Commercial Distribution

  • 00852169008294 ()

  • Total Volume: 255 Milliliter
MPN2020

  • Total microprotein IVD, reagent

ClearChem Diagnostics Inc. MicroAlbumin - 00852169008270

In Vitro Diagnostics testing kit R1:4X20mL, R2:2X10mL
CLEARCHEM DIAGNOSTICS INC.
MAL1010
In Commercial Distribution

  • 00852169008270 ()

  • Total Volume: 100 Milliliter
MAL1010

  • Microalbumin IVD, reagent
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