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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THC LEVEL 10
UTAK LABORATORIES, INC.
THC 10 U F WDH
In Commercial Distribution

  • B800THC10UFWDH5 ()
  • B800THC10UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 10 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
THC LEVEL 0
UTAK LABORATORIES, INC.
THC 0 U F WDH
In Commercial Distribution

  • B800THC0UFWDH5 ()
  • B800THC0UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 0 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
PANEL 1 THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020004
In Commercial Distribution

  • 10858904006102 ()
  • 00858904006105 ()
DTH-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC150/MOR/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD03061 ()
  • B115ABCARD03060 ()
ABCard-03-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC300/MET1000/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD03031 ()
  • B115ABCARD03030 ()
ABCard-03-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC150/ME500T/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD03021 ()
  • B115ABCARD03020 ()
ABCard-03-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/COC/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD03011 ()
  • B115ABCARD03010 ()
ABCard-03-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC 1000ng, 100mL
BIOCHEMICAL DIAGNOSTICS INC
18000454
In Commercial Distribution

  • 00810042682986 ()
18000454

  • Multiple drugs of abuse IVD, control
Cable,ECG,Shielded,3 Lead,AAMI,DS com, 10'
Advantage Medical Electronics, LLC
CB-73340R
In Commercial Distribution

  • 00849593013796 ()


  • Electrical-only medical device connection cable, reusable
3-LD Set, PINCH to TWIN, A, 29, TEL COM
CURBELL MEDICAL PRODUCTS, INC.
LW-3300029/3AT
In Commercial Distribution

  • 00840828148764 ()
9233

  • Electrocardiographic lead set, reusable
BT 022 ROTH COM CV GING UR DB (10)
ORTHO ORGANIZERS, INC.
4016-362-10
In Commercial Distribution

  • 00190707102791 ()


  • Orthodontic tube
BT 018 ROTH COM CV GING UL DB (10)
ORTHO ORGANIZERS, INC.
4016-361-10
In Commercial Distribution

  • 00190707102784 ()


  • Orthodontic tube
***DISC*JUXTALITE HD 28 CM LL (M) W/ COM
MEDI MANUFACTURING, INC.
33024017
Not in Commercial Distribution

  • 00636257002575 ()


  • Compression bandaging kit
***DISC*JUXTALITE HD 33 CM LL (XL) W COM
MEDI MANUFACTURING, INC.
33036017
Not in Commercial Distribution

  • 00636257002544 ()


  • Compression bandaging kit
***DISC*JUXTALITE HD 33 CM LL (L) W/ COM
MEDI MANUFACTURING, INC.
33035017
Not in Commercial Distribution

  • 00636257002520 ()


  • Compression bandaging kit
***DISC*JUXTALITE HD 33 CM LL (M) W/ COM
MEDI MANUFACTURING, INC.
33034017
Not in Commercial Distribution

  • 00636257002506 ()


  • Compression bandaging kit
***DISC*JUXTALITE HD 33 CM LL (S) W/ COM
MEDI MANUFACTURING, INC.
33033017
Not in Commercial Distribution

  • 00636257002490 ()


  • Compression bandaging kit
***DISC*JUXTALITE HD 28 CM LL (XL) W COM
MEDI MANUFACTURING, INC.
33026017
Not in Commercial Distribution

  • 00636257002469 ()


  • Compression bandaging kit
***DISC*JUXTALITE HD 28 CM LL (L) W/ COM
MEDI MANUFACTURING, INC.
33025017
Not in Commercial Distribution

  • 00636257002445 ()


  • Compression bandaging kit
***DISC*JUXTALITE HD 28 CM LL (S) W/ COM
MEDI MANUFACTURING, INC.
33023017
Not in Commercial Distribution

  • 00636257002421 ()


  • Compression bandaging kit
.022 UL6 Conv Com Buccal Tube Roth Ging DB
ORTHO ORGANIZERS, INC.
4016-363-10
In Commercial Distribution

  • 00190707087739 ()


  • Orthodontic tube
.018 UR6 Conv Com Buccal Tube Roth Ging DB
ORTHO ORGANIZERS, INC.
4016-360-10
In Commercial Distribution

  • 00190707087722 ()


  • Orthodontic tube
.022 UL6 Conv Com Buccal Tube Roth Ging Weldable
ORTHO ORGANIZERS, INC.
4016-263-10
In Commercial Distribution

  • 00190707087562 ()


  • Orthodontic tube
.022 UR6 Conv Com Buccal Tube Roth Ging Weldable
ORTHO ORGANIZERS, INC.
4016-262-10
In Commercial Distribution

  • 00190707087555 ()


  • Orthodontic tube
.018 UL6 Conv Com Buccal Tube Roth Ging Weldable
ORTHO ORGANIZERS, INC.
4016-261-10
In Commercial Distribution

  • 00190707087548 ()


  • Orthodontic tube
.018 UR6 Conv Com Buccal Tube Roth Ging Weldable
ORTHO ORGANIZERS, INC.
4016-260-10
In Commercial Distribution

  • 00190707087531 ()


  • Orthodontic tube
COC/MET1000/THC DipCard
Twin Spirit Inc.
30300D
Not in Commercial Distribution

  • 00859144006320 ()
30300D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC Rapid Test Cassette
ACRO BIOTECH INC
1
In Commercial Distribution

  • 00853691007168 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
15 THC test dip-cards
IDUN SOLUTIONS LLC
IDTH-115-15P
Not in Commercial Distribution

  • 00857275007124 ()
  • 00857275007025 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Immutest AMP+MET+THC
AMEDITECH INC.
IMD-3AMJ
Not in Commercial Distribution

  • 00816565021295 ()
IMD-3AMJ

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC single drug dipcard
AMEDITECH INC.
IMD-THC
Not in Commercial Distribution

  • 00816565020069 ()
IMD-THC

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
1-Strip; THC Marijuana/Cannabinoids
WONDFO USA CO., LTD.
WDTH-101
In Commercial Distribution

  • 00816862025811 ()
WDTH-101

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1-Strip; THC Marijuana/Cannabinoids
WONDFO USA CO., LTD.
WDTH-101-25B
In Commercial Distribution

  • 10816862023258 ()
  • 00816862023251 ()
  • 00816862023268 ()
WDTH-101-25B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel Card; THC
WONDFO USA CO., LTD.
DWDTH-114-15BX-A
In Commercial Distribution

  • 10816862022305 ()
  • 00816862022308 ()
  • 00816862022315 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel Card; THC
WONDFO USA CO., LTD.
DWDTH-114-5BX-A
In Commercial Distribution

  • 00816862022292 ()
  • 00816862022278 ()
  • 00816862022285 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1-Strip; THC Marijuana/Cannabinoids
WONDFO USA CO., LTD.
WDTH-101
In Commercial Distribution

  • 10816862020813 ()
  • 00816862020816 ()
  • 00816862029819 ()
WDTH-101

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OXY THC LEVEL 2
UTAK LABORATORIES, INC.
OXY THC 2 F OL
In Commercial Distribution

  • B800OXYTHC2FOL5 ()
  • B800OXYTHC2FOL0 ()

  • Total Volume: 25 Milliliter
OXY THC 2 F OL

  • Multiple-type clinical chemistry analyte profile IVD, control
OXY THC LEVEL 1
UTAK LABORATORIES, INC.
OXY THC 1 F OL
In Commercial Distribution

  • B800OXYTHC1FOL5 ()
  • B800OXYTHC1FOL0 ()

  • Total Volume: 25 Milliliter
OXY THC 1 F OL

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU THC LEVEL 1
UTAK LABORATORIES, INC.
DAU THC 1 F OL
In Commercial Distribution

  • B800DAUTHC1FOL5 ()
  • B800DAUTHC1FOL0 ()

  • Total Volume: 25 Milliliter
DAU THC 1 F OL

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 9
UTAK LABORATORIES, INC.
THC+ 9 U F WCT
In Commercial Distribution

  • B800THC9UFWCT5 ()
  • B800THC9UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 9 U F WCT

  • Multiple-type clinical chemistry analyte profile IVD, control
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