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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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Light Based Over-The-Counter Hair Removal
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
PL5137
In Commercial Distribution

  • 00069055886359 ()
  • 10069055886356 ()


  • Home-use intense pulsed light hair removal unit
Light Based Over-The-Counter Hair Removal
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
PL5117
Not in Commercial Distribution

  • 10069055886349 ()
  • 00069055886342 ()


  • Home-use intense pulsed light hair removal unit
Light Based Over-The-Counter Hair Removal
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
BD5004
In Commercial Distribution

  • 00069055886199 ()
  • 10069055886196 ()


  • Cosmetic red-light phototherapy system, home-use
Light Based Over-The-Counter Hair Removal
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
BD5007
In Commercial Distribution

  • 10069055880958 ()
  • 00069055880951 ()


  • Cosmetic red-light phototherapy system, home-use
Omnipod 5 Controller APP
Insulet Corporation
M009-3P-AP
In Commercial Distribution

  • 10385083000565 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Starter Kit mg/dl
Insulet Corporation
SKT-M001-G-X9
In Commercial Distribution

  • 10385083000503 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Controller APP
Insulet Corporation
M009-S-AP
In Commercial Distribution

  • 10385083000336 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Actual downloadable APP, called Omnipod 5 Controller APP
Insulet Corporation
1.0
In Commercial Distribution

  • 10385081120302 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Immunoassay for the detection of the following drug substance(s) in human urine: BAR / BZD / COC / M-AMP / THC
RAPID DIAGNOSTICS INC
07RD7064-38
In Commercial Distribution

  • 00817830021682 ()

  • Length: 75 Millimeter
07RD7064-38

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / OPI / THC
RAPID DIAGNOSTICS INC
07RD7064-37
In Commercial Distribution

  • 00817830021675 ()

  • Length: 75 Millimeter
07RD7064-37

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / OPI / OXY
RAPID DIAGNOSTICS INC
07RD7064-36
In Commercial Distribution

  • 00817830021668 ()

  • Length: 75 Millimeter
07RD7064-36

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BAR / COC / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD7064-35
In Commercial Distribution

  • 00817830021651 ()

  • Length: 75 Millimeter
07RD7064-35

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD / OPI-II/ OXY
RAPID DIAGNOSTICS INC
07RD7064-34A
In Commercial Distribution

  • 00817830021644 ()

  • Length: 75 Millimeter
07RD7064-34A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD / OPI / OXY
RAPID DIAGNOSTICS INC
07RD7064-34
In Commercial Distribution

  • 00817830021637 ()

  • Length: 75 Millimeter
07RD7064-34

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BAR / BZD / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD7064-32
In Commercial Distribution

  • 00817830021620 ()

  • Length: 75 Millimeter
07RD7064-32

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / COC / M-AMP / MTD
RAPID DIAGNOSTICS INC
07RD7064-30
In Commercial Distribution

  • 00817830021613 ()

  • Length: 75 Millimeter
07RD7064-30

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / MTD / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7064-29A
In Commercial Distribution

  • 00817830021606 ()

  • Length: 75 Millimeter
07RD7064-29A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7064-29
In Commercial Distribution

  • 00817830021590 ()

  • Length: 75 Millimeter
07RD7064-29

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI-II
RAPID DIAGNOSTICS INC
07RD7064-24A
In Commercial Distribution

  • 00817830021583 ()

  • Length: 75 Millimeter
07RD7064-24A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI
RAPID DIAGNOSTICS INC
07RD7064-24
In Commercial Distribution

  • 00817830021576 ()

  • Length: 75 Millimeter
07RD7064-24

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / MTD / OPI-II
RAPID DIAGNOSTICS INC
07RD7064-23A
In Commercial Distribution

  • 00817830021569 ()

  • Length: 75 Millimeter
07RD7064-23A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / MTD / OPI
RAPID DIAGNOSTICS INC
07RD7064-23
In Commercial Distribution

  • 00817830021552 ()

  • Length: 75 Millimeter
07RD7064-23

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / COC / MTD / OPI-II
RAPID DIAGNOSTICS INC
07RD7064-22A
In Commercial Distribution

  • 00817830021545 ()

  • Length: 75 Millimeter
07RD7064-22A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / COC / MTD / OPI
RAPID DIAGNOSTICS INC
07RD7064-22
In Commercial Distribution

  • 00817830021538 ()

  • Length: 75 Millimeter
07RD7064-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / MTD / OPI-II / PCP / THC
RAPID DIAGNOSTICS INC
07RD7064-21A
In Commercial Distribution

  • 00817830021521 ()

  • Length: 75 Millimeter
07RD7064-21A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / MTD / OPI / PCP / THC
RAPID DIAGNOSTICS INC
07RD7064-21
In Commercial Distribution

  • 00817830021514 ()

  • Length: 75 Millimeter
07RD7064-21

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / COC / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7064-20A
In Commercial Distribution

  • 00817830021507 ()

  • Length: 75 Millimeter
07RD7064-20A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / COC / OPI / THC
RAPID DIAGNOSTICS INC
07RD7064-20
In Commercial Distribution

  • 00817830021491 ()

  • Length: 75 Millimeter
07RD7064-20

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / BUP / COC / MTD / OPI-II
RAPID DIAGNOSTICS INC
07RD7064-19
In Commercial Distribution

  • 00817830021484 ()

  • Length: 75 Millimeter
07RD7064-19

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / BUP / COC / OPI-II
RAPID DIAGNOSTICS INC
07RD7064-14A
In Commercial Distribution

  • 00817830021477 ()

  • Length: 75 Millimeter
07RD7064-14A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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