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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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THC LEVEL 10 - B800THC10UFWDH0

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 - B800THC0UFWDH0

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

reditest® - 10858904006102

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

Advin Multi-Drug Screen Test - B115ABCARD03061

COC150/MOR/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

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

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

Advin Multi-Drug Screen Test - B115ABCARD03031

COC300/MET1000/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

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

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

Advin Multi-Drug Screen Test - B115ABCARD03021

COC150/ME500T/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

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

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

Advin Multi-Drug Screen Test - B115ABCARD03011

AMP/COC/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

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

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

DETECTABUSE - 00810042682986

THC 1000ng, 100mL
BIOCHEMICAL DIAGNOSTICS INC
18000454
In Commercial Distribution

  • 00810042682986 ()
18000454

  • Multiple drugs of abuse IVD, control

AMC - 00849593013796

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 - 00840828148764

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

MASEL Buccal Tubes - 00190707102791

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

  • 00190707102791 ()


  • Orthodontic tube

MASEL Buccal Tubes - 00190707102784

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

  • 00190707102784 ()


  • Orthodontic tube

MEDI - 00636257002575

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

  • 00636257002575 ()


  • Compression bandaging kit

MEDI - 00636257002544

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

  • 00636257002544 ()


  • Compression bandaging kit

MEDI - 00636257002520

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

  • 00636257002520 ()


  • Compression bandaging kit

MEDI - 00636257002506

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

  • 00636257002506 ()


  • Compression bandaging kit

MEDI - 00636257002490

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

  • 00636257002490 ()


  • Compression bandaging kit

MEDI - 00636257002469

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

  • 00636257002469 ()


  • Compression bandaging kit

MEDI - 00636257002445

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

  • 00636257002445 ()


  • Compression bandaging kit

MEDI - 00636257002421

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

  • 00636257002421 ()


  • Compression bandaging kit

Buccal Tube Direct Bond - 00190707087739

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

  • 00190707087739 ()


  • Orthodontic tube

Buccal Tube Direct Bond - 00190707087722

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

  • 00190707087722 ()


  • Orthodontic tube

Buccal Tubes Weldable - 00190707087562

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

  • 00190707087562 ()


  • Orthodontic tube

Buccal Tubes Weldable - 00190707087555

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

  • 00190707087555 ()


  • Orthodontic tube

Buccal Tubes Weldable - 00190707087548

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

  • 00190707087548 ()


  • Orthodontic tube

Buccal Tubes Weldable - 00190707087531

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

  • 00190707087531 ()


  • Orthodontic tube

DrugSmart Dip - 00859144006320

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 - 00853691007168

THC Rapid Test Cassette
ACRO BIOTECH INC
1
In Commercial Distribution

  • 00853691007168 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

Preknow THC (Marijuana) Single Drug Screen Test (15 Dipcards) - 00857275007124

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 Drugs of Abuse Screen Device - 00816565021295

Immutest AMP+MET+THC
AMEDITECH INC.
IMD-3AMJ
Not in Commercial Distribution

  • 00816565021295 ()
IMD-3AMJ

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

ImmuTest Drugs of Abuse Screen Card - 00816565020069

THC single drug dipcard
AMEDITECH INC.
IMD-THC
Not in Commercial Distribution

  • 00816565020069 ()
IMD-THC

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

Wondfo Drug Test Strip - 00816862025811

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

Wondfo - 00816862023251

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

PrimeScreen - 00816862022308

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

PrimeScreen - 00816862022278

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

Wondfo Drug Test Strip - 00816862020816

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 - B800OXYTHC2FOL0

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 - B800OXYTHC1FOL0

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 - B800DAUTHC1FOL0

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 - B800THC9UFWCT0

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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