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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5-Panel Card; AMP,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
WDOA-254
In Commercial Distribution

  • 00816862025569 ()
WDOA-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card; AMP,COC,OPI,PCP,THC
WONDFO USA CO., LTD.
WDOA-154
In Commercial Distribution

  • 00816862025538 ()
WDOA-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cube; AMP, COC, MET, OPI, THC
WONDFO USA CO., LTD.
ODOA-256EUO
In Commercial Distribution

  • 10816862022831 ()
  • 00816862022834 ()
  • 00816862022841 ()
ODOA-256EUO

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card; AMP,BZO,COC,OPI,THC
WONDFO USA CO., LTD.
WDOA-754
In Commercial Distribution

  • 00816862025743 ()
WDOA-754

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card; BZO,COC,mAMP,MOP,THC
WONDFO USA CO., LTD.
WDOA-655
In Commercial Distribution

  • 00816862025712 ()
WDOA-655

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card; BZO,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
WDOA-654
In Commercial Distribution

  • 00816862025705 ()
WDOA-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cup; BZO,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
TDOA-654
In Commercial Distribution

  • 00816862025279 ()
TDOA-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cup; AMP,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
TDOA-254
In Commercial Distribution

  • 00816862025125 ()
TDOA-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cup; AMP,COC,OPI,PCP,THC
WONDFO USA CO., LTD.
TDOA-154
In Commercial Distribution

  • 00816862025088 ()
TDOA-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3-Panel Preview Dip Card; COC,mAMP,THC
WONDFO USA CO., LTD.
PRE-WDOA-232
In Commercial Distribution

  • 00816862022506 ()
  • 00816862022483 ()
  • 00816862022490 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cube; AMP,COC,MET,OPI,THC
WONDFO USA CO., LTD.
DODOA-256-EUO-25BX-B
In Commercial Distribution

  • 10816862022190 ()
  • 00816862022193 ()
  • 00816862022209 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
20 tests per kit;THC Single Panel
EASY HEALTHCARE CORPORATION
EDTH-114
In Commercial Distribution

  • 10810038632015 ()
  • 00810038632018 ()
  • 30810038632019 ()
EDTH-114-20

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
5 tests per kit;THC Single Panel
EASY HEALTHCARE CORPORATION
EDTH-114
In Commercial Distribution

  • 10810038631636 ()
  • 00810038631639 ()
  • 30810038631630 ()
EDTH-114-5

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
15 tests per kit;THC Single Panel
EASY HEALTHCARE CORPORATION
ASTH-114C
In Commercial Distribution

  • 10810038634088 ()
  • 00810038634081 ()
  • 30810038634082 ()
ASTH-114-15C15

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
AccuSign® THC card; 10 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
DOA-201-10-02
In Commercial Distribution

  • 10743816000044 ()
DOA-201-10-02

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
AccuSign® THC card; 35 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
DOA-201-35-02
In Commercial Distribution

  • 10743816000037 ()
DOA-201-35-02

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
THC-1011
In Commercial Distribution

  • 06974246460680 ()
THC-1011

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
THC-1011
In Commercial Distribution

  • 06974246460567 ()
THC-1011

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
Microgenics Corporation
1557548
In Commercial Distribution

  • 00884883001947 ()


  • Cannabinoid/cannabinoid metabolite IVD, calibrator
No Description
Microgenics Corporation
1557530
In Commercial Distribution

  • 00884883001930 ()


  • Cannabinoid/cannabinoid metabolite IVD, calibrator
No Description
Microgenics Corporation
1557521
In Commercial Distribution

  • 00884883001923 ()


  • Cannabinoid/cannabinoid metabolite IVD, calibrator
No Description
Microgenics Corporation
1557513
In Commercial Distribution

  • 00884883001916 ()


  • Cannabinoid/cannabinoid metabolite IVD, calibrator
No Description
Microgenics Corporation
1557505
In Commercial Distribution

  • 00884883001909 ()


  • Cannabinoid/cannabinoid metabolite IVD, calibrator
No Description
Microgenics Corporation
100100
In Commercial Distribution

  • 00884883001527 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
Microgenics Corporation
100091
In Commercial Distribution

  • 00884883001466 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
Microgenics Corporation
10016433
In Commercial Distribution

  • 00884883012561 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
MASIMO CORPORATION
1853
In Commercial Distribution

  • 00843997001380 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
1810
In Commercial Distribution

  • 00843997001359 ()


  • Electrical-only medical device connection cable, reusable
Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAITB607EW
In Commercial Distribution

  • 08800036204159 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAITB605EW
In Commercial Distribution

  • 08800036204142 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAITB604EW
In Commercial Distribution

  • 08800036204135 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAITB40437
In Commercial Distribution

  • 08800036204128 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAITB40435
In Commercial Distribution

  • 08800036204111 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAITB40434
In Commercial Distribution

  • 08800036204104 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAIT40437
In Commercial Distribution

  • 08800036204098 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAIT40435
In Commercial Distribution

  • 08800036204081 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAIT40434
In Commercial Distribution

  • 08800036204074 ()


  • Dental implant system
AllSource DRUG DETECTOR, Single-Panel (THC 50), 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
ALLDTHR
In Commercial Distribution

  • 30850054867620 ()
  • 00850054867629 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Chemtrue® THC Dip Card Test, 25pcs/kit
CHEMTRON BIOTECH INC
711A06CT
In Commercial Distribution

  • 00850019007206 ()
711A06CT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Urine based drug of abuse test for THC
PHAMATECH, INCORPORATED
9078T
In Commercial Distribution

  • 00674033090781 ()


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