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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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IV Start Kit
STRADIS MEDICAL, LLC
IM1207C
In Commercial Distribution

  • M752IM1207C5 ()
  • M752IM1207C0 ()


  • Peripheral intravenous catheterization support kit
IV Start Kit
STRADIS MEDICAL, LLC
IM1205C
In Commercial Distribution

  • M752IM1205C5 ()
  • M752IM1205C0 ()


  • Peripheral intravenous catheterization support kit
IV Start Kit
STRADIS MEDICAL, LLC
IM1200C
In Commercial Distribution

  • M752IM1200C5 ()
  • M752IM1200C0 ()


  • Peripheral intravenous catheterization support kit
Isolation Kit
STRADIS MEDICAL, LLC
IK
Not in Commercial Distribution

  • M752IK1 ()
  • M752IK5 ()


  • Visitor hygiene clothing kit
PRP Accessories Kit
STRADIS MEDICAL, LLC
HM-ACCESS
In Commercial Distribution

  • M752HMACCESS5 ()
  • M752HMACCESS0 ()


  • Haematological concentrate system preparation kit, platelet concentration
Dressing Kit
STRADIS MEDICAL LLC
HHSBRF-661
In Commercial Distribution

  • M752HHSBRF6610 ()
  • M752HHSBRF6615 ()


  • Wound dressing kit, non-medicated
SYRINGE CAPS
STRADIS MEDICAL LLC
HCTBBD-100
In Commercial Distribution

  • M752HCTBBD1000 ()
  • M752HCTBBD1001 ()
  • M752HCTBBD1005 ()


  • Luer-formatted protective cap
Dialysis Catheter Dressing Change For Dialysis Catheters Only
STRADIS MEDICAL, LLC
HCT9958CP
In Commercial Distribution

  • M752HCT9958CP0 ()
  • M752HCT9958CP5 ()


  • General surgical procedure kit, non-medicated, single-use
Dressing Change Tray
STRADIS MEDICAL, LLC
HCT9948CPA
Not in Commercial Distribution

  • M752HCT9948CPA0 ()
  • M752HCT9948CPA5 ()


  • Wound dressing kit, medicated
Dressing Change Tray W/ Biopatch
STRADIS MEDICAL LLC
HCT9948BP1VG0
In Commercial Distribution

  • M752HCT9948BP1VG5 ()
  • M752HCT9948BP1VG0 ()


  • Wound dressing kit, medicated
Dressing Change Tray W/ Biopatch
STRADIS MEDICAL LLC
HCT9948BP-1
In Commercial Distribution

  • M752HCT9948BP15 ()
  • M752HCT9948BP10 ()


  • Wound dressing kit, medicated
Ultrasound Procedure Kit
STRADIS MEDICAL LLC
HCT9849-1
In Commercial Distribution

  • M752HCT984915 ()
  • M752HCT984910 ()


  • Topical coupling gel, sterile
Ultrasound Procedure Kit
STRADIS MEDICAL, LLC
HCT9849
In Commercial Distribution

  • M752HCT98490 ()
  • M752HCT98495 ()


  • Topical coupling gel, sterile
Central Line Dressing Kit W/BP
STRADIS MEDICAL, LLC
HCT9555AI
In Commercial Distribution

  • M752HCT9555AI5 ()
  • M752HCT9555AI0 ()


  • Wound dressing kit, medicated
Dressing Change Tray
STRADIS MEDICAL, LLC
HCT9450CP
Not in Commercial Distribution

  • M752HCT9450CP0 ()
  • M752HCT9450CP5 ()


  • Wound dressing kit, medicated
Dressing Change Tray With - Biopatch
STRADIS MEDICAL, LLC
HCT9420BP
Not in Commercial Distribution

  • M752HCT9420BP0 ()
  • M752HCT9420BP5 ()


  • Wound dressing kit, medicated
Dressing Change Kit
STRADIS MEDICAL, LLC
HCT9412CP-1
Not in Commercial Distribution

  • M752HCT9412CP10 ()
  • M752HCT9412CP15 ()


  • Wound dressing kit, medicated
Central Line Dressing Change Kit
STRADIS MEDICAL, LLC
HCT8882CP
Not in Commercial Distribution

  • M752HCT8882CP0 ()
  • M752HCT8882CP5 ()


  • Wound dressing kit, medicated
Dressing Change Tray
STRADIS MEDICAL, LLC
HCT8844BP
Not in Commercial Distribution

  • M752HCT8844BP0 ()
  • M752HCT8844BP5 ()


  • Wound dressing kit, medicated
PICC Tray
STRADIS MEDICAL, LLC
HCT8558PK-2
In Commercial Distribution

  • M752HCT8558PK25 ()
  • M752HCT8558PK21 ()


  • General surgical procedure kit, medicated
PICC Tray
STRADIS MEDICAL, LLC
HCT8558PK-1
In Commercial Distribution

  • M752HCT8558PK15 ()
  • M752HCT8558PK11 ()


  • General surgical procedure kit, medicated
Dressing Change Tray
STRADIS MEDICAL LLC
HCT8473-2
In Commercial Distribution

  • M752HCT847325 ()
  • M752HCT847320 ()


  • Wound dressing kit, medicated
Dressing Change Tray
STRADIS MEDICAL, LLC
HCT8473-1
Not in Commercial Distribution

  • M752HCT847310 ()
  • M752HCT847315 ()


  • Wound dressing kit, medicated
Dressing Change Tray W/ Chlorhexidine
STRADIS MEDICAL, LLC
HCT8443CP-3
In Commercial Distribution

  • M752HCT8443CP30 ()
  • M752HCT8443CP35 ()


  • Wound dressing kit, medicated
Dressing Change Tray W/ TEG & CHG
STRADIS MEDICAL, LLC
HCT8440TC
Not in Commercial Distribution

  • M752HCT8440TC0 ()
  • M752HCT8440TC5 ()


  • Wound dressing kit, medicated
MAX BARRIER PICC INSERTION TRAY
STRADIS MEDICAL LLC
HCT8428CP-2
In Commercial Distribution

  • M752HCT8428CP25 ()
  • M752HCT8428CP20 ()


  • General surgical procedure kit, non-medicated, single-use
Max Barrier PICC Insertion Tray
STRADIS MEDICAL, LLC
HCT8428CP-1
In Commercial Distribution

  • M752HCT8428CP15 ()
  • M752HCT8428CP11 ()


  • General surgical procedure kit, non-medicated, single-use
Immunoassay for the detection of buprenorphine in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7106
In Commercial Distribution

  • M90107RD71061 ()
  • M90107RD71060 ()

  • Length: 75 Millimeter
07RD7106

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI / OXY / PCP
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-15
In Commercial Distribution

  • M90107RD7073151 ()
  • M90107RD7073150 ()

  • Length: 75 Millimeter
07RD7073-15

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / OPI / THC / PCP / OXY
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-09
In Commercial Distribution

  • M90107RD7073091 ()
  • M90107RD7073090 ()

  • Length: 75 Millimeter
07RD7073-09

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