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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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Planatome #10 Scalpel
Planatome, LLC
PL-10
In Commercial Distribution

  • 00860003534601 ()
  • 00860003534649 ()
  • 00860003534656 ()

  • Weight: 0.636 Gram


  • Manual scalpel blade, single-use
10/17/2022
GENCHEM INC
GEN-TP3
Not in Commercial Distribution

  • 00851445007303 ()
GEN-TP3

  • Total protein IVD, kit, enzyme spectrophotometry
10/17/2022
GENCHEM INC
GEN-TP
Not in Commercial Distribution

  • 00851445007297 ()
GEN-TP

  • Total protein IVD, kit, enzyme spectrophotometry
10/17/2022
GENCHEM INC
GEN-TBILI R3
Not in Commercial Distribution

  • 00851445007280 ()
GEN-TBILI R3

  • Total bilirubin IVD, kit, enzyme spectrophotometry
10/17/2022
GENCHEM INC
GEN-TBILI R2
Not in Commercial Distribution

  • 00851445007273 ()
GEN-TBILI R2

  • Total bilirubin IVD, kit, enzyme spectrophotometry
10/17/2022
GENCHEM INC
GEN-TBILI R1
Not in Commercial Distribution

  • 00851445007266 ()
GEN-TBILI R1

  • Total bilirubin IVD, kit, enzyme spectrophotometry
10/17/2022
GENCHEM INC
GEN-ISE REFERENCE
Not in Commercial Distribution

  • 00851445007259 ()
GEN-ISE REFERENCE

  • Ion selective electrode (ISE) reference solution IVD, reagent
10/17/2022
GENCHEM INC
GEN-ISE BUFFER
Not in Commercial Distribution

  • 00851445007242 ()
GEN-ISE BUFFER

  • Ion selective electrode (ISE) reference solution IVD, reagent
10/17/2022
GENCHEM INC
GEN-GLU4
Not in Commercial Distribution

  • 00851445007235 ()
GEN-GLU4

  • Glucose IVD, kit, spectrophotometry
10/17/2022
GENCHEM INC
GEN-GLU LX
Not in Commercial Distribution

  • 00851445007228 ()
GEN-GLU LX

  • Glucose IVD, kit, spectrophotometry
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