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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13-Panel T-Cup;AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
TDOA-2135
In Commercial Distribution

  • 00816862025101 ()
TDOA-2135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® 7-Panel T-Cup; 25 per box; AMP,BZO,COC,MET,OPI,OXY,THC
WONDFO USA CO., LTD.
DTDOA-274-25BX-A
In Commercial Distribution

  • 10816862024910 ()
  • 00816862024913 ()
  • 00816862024906 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® 5-Panel T-Square with indicator; 5 per Box; AMP, COC, MET, OPI, THC
WONDFO USA CO., LTD.
DQODOA-256EUO-I-5BX-A
In Commercial Distribution

  • 10816862023906 ()
  • 00816862023909 ()
  • 00816862023916 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9-Panel T-Square no THC with Indicator; AMP,BAR,COC,MDMA,MET,MTD,OPI,OXY,PCP
WONDFO USA CO., LTD.
QODOA-496NTEUO-I
In Commercial Distribution

  • 10816862023456 ()
  • 00816862023459 ()
  • 00816862023466 ()
QODOA-496NTEUO-I

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup Flat; AMP, BAR, BUP, BZO, COC, mAMP, MDMA, MOP, MTD, OXY, PCP, THC
WONDFO USA CO., LTD.
FDOA-6125
In Commercial Distribution

  • 00816862022407 ()
  • 00816862022384 ()
  • 00816862022391 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,MDMA,MTD,OPI,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
CDOA-3124
In Commercial Distribution

  • 10816862021537 ()
  • 00816862021530 ()
  • 00816862028539 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card for Cup; AMP,COC,mAMP,OPI,THC with 3 AD (OX,SG,pH)
WONDFO USA CO., LTD.
WDOA-254A-A3
In Commercial Distribution

  • 10816862021315 ()
  • 00816862021318 ()
  • 00816862028317 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Preview Cup; AMP,BAR,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
PRE-PDOA-7125
In Commercial Distribution

  • 10816862021186 ()
  • 00816862021189 ()
  • 00816862028188 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Preview Cup; AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
PRE-PDOA-6125
In Commercial Distribution

  • 10816862021179 ()
  • 00816862021172 ()
  • 00816862028171 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup; AMP500,BAR,BUP,BZO,COC150,mAMP500,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
TDOA-3135
In Commercial Distribution

  • 10816862020929 ()
  • 00816862020922 ()
  • 00816862025927 ()
TDOA-3135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11-Panel Dip Drug Screen (THC/COC/MOP/AMP/MET/PCP/BAR/BZO/MDMA/MTD/OXY)
WONDFO USA CO., LTD.
WD-11MT
In Commercial Distribution

  • 10816862020370 ()
  • 00816862020373 ()
  • 00816862029376 ()
WD-11MT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-3104A3
In Commercial Distribution

  • 10816862020189 ()
  • 00816862020182 ()
  • 00816862029185 ()
TDOA-3104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup;AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
TDOA-2135
In Commercial Distribution

  • 10816862020103 ()
  • 00816862020106 ()
  • 00816862029109 ()
TDOA-2135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: THC / COC
RAPID DIAGNOSTICS INC
07RD7108-01
In Commercial Distribution

  • 00817830022559 ()

  • Height: 74 Millimeter
07RD7108-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7108-01
In Commercial Distribution

  • M90107RD7108010 ()

  • Length: 74 Millimeter
07RD7108-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: MAMP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-03
In Commercial Distribution

  • M90107RD7061031 ()
  • M90107RD7061030 ()

  • Length: 75 Millimeter
07RD7061-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-01
In Commercial Distribution

  • M90107RD7061011 ()
  • M90107RD7061010 ()

  • Length: 75 Millimeter
07RD7061-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel DOA Cup, AMP500/BUP/BZO/COC150/FYL5/MET500/MOR/MTD/OXY/THC, 25tests/kit
CHEMTRON BIOTECH INC
PCU-10FCW-25
In Commercial Distribution

  • 00812203030766 ()
PCU-10FCW-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel DOA Dip, AMP/BZO/COC/MTD/MDMA/MET/MOR/OXY/BUP/TML/FYL5/THC
CHEMTRON BIOTECH INC
711L10-G
In Commercial Distribution

  • 00812203030711 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel DrugSmart Dip, AMP300/MOR/COC150/THC/MET500/PCP/BAR/BZO/MTD/MDMA/OXY/BUP
CHEMTRON BIOTECH INC
C-31223D
In Commercial Distribution

  • 00812203030179 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel DOA Cup, COC/AMP/MET/THC/MTD/MDMA/OPI/OXY/PPX/PCP/BAR/BZO
CHEMTRON BIOTECH INC
712L14
In Commercial Distribution

  • 00812203030148 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel DOA Cup, THC/COC150/MOR/AMP500/MET500/BAR/BZO/BUP/MTD/MDMA/OXY/PCP
CHEMTRON BIOTECH INC
712L13
In Commercial Distribution

  • 00812203030087 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel DOA Cup, AMP/BAR/BZO/COC/MET/MTD/MOR/PCP/PPX/THC - 25tests/kit
CHEMTRON BIOTECH INC
712J08
In Commercial Distribution

  • 00812203030049 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI300, AMP, MET, MDMA, BAR, BZO, MTD, OXY Drugs of Abuse Test Cup
AMEDITECH INC.
C-C1016A
Not in Commercial Distribution

  • 00816565020564 ()
C-C1016A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 panel test cup, COC/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-3P
Not in Commercial Distribution

  • 00816565020199 ()
IMCA-3P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(BZO/BAR)+(COC/THC)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+ MET1000 + OPI300 multiple drugs dipcard
AMEDITECH INC.
IMD-12MO3
Not in Commercial Distribution

  • 00816565020076 ()
IMD-12MO3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA-154-181(COC/AMP/THC/OPI/PCP)MULTI-DRUG 5 PANEL SCREEN TEST (DOA-154-181) previous (GTIN 10869419000240)
Quest Diagnostics
DOA-154-181
In Commercial Distribution

  • 00869419000243 ()
  • 20869419000247 ()
DOA-154-ONC62B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QuikStrip Multidrug 5 Test, AMP 500, COC 300, MET 500, OP I 2000, THC 50
SYNTRON BIORESEARCH, INC.
30500
In Commercial Distribution

  • 20748349000377 ()
  • 10748349000370 ()
  • 00748349000373 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
AMP/BAR/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA12061 ()
  • B115ABCUPA12060 ()
ABCupA-12-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA12021 ()
  • B115ABCUPA12020 ()
ABCupA-12-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/TCA/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA12011 ()
  • B115ABCUPA12010 ()
ABCupA-12-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA12061 ()
  • B115ABCARDA12060 ()
ABCardA-12-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA12021 ()
  • B115ABCARDA12020 ()
ABCardA-12-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/TCA/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA12011 ()
  • B115ABCARDA12010 ()
ABCardA-12-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Blade
Dev4
CT-2003NS
In Commercial Distribution

  • 00860011634836 ()
  • 10860011634833 ()


  • Manual scalpel blade, reusable
Description of the test packs kit (TSO3 product code 44020): • Syringe with plunger • Diffusion restrictor
TSO3 Inc
44020
In Commercial Distribution

  • 00690455440201 ()
44020

  • Biological sterilization indicator
The 125-280 Solution™ product is 50% liquid hydrogen peroxide solution (CAS# 7722-84-1) provided in 280 mL bottles. The active ingredient is 50% H2O2 by weight and the inactive ingredients are water and stabilizing agents. The 125-280 Solution™ product is a stabilized analytical grade. The 125-280 Solution™ product is supplied in a bottle specially designed for use only in the STERIZONE® VP4 Sterilizer
TSO3 Inc
44010
In Commercial Distribution

  • 00690455045604 ()
  • 00690455440102 ()
44010

  • Hydrogen peroxide device sterilant
The STERIZONE® VP4 Sterilizer currently offers a single preset sterilization cycle (Cycle 1) designed for the sterilization of a wide variety of loads consisting of general instruments, single, double or multi- channel flexible endoscopes, and rigid and semi-rigid channeled devices including single channel and double channel rigid endoscopes. The STERIZONE® VP4 Sterilizer uses dual sterilants, vaporized hydrogen peroxide (H2O2) and ozone (O3), in a multiphase process, and is the only dual-sterilant sterilizer cleared for use in the United States
TSO3 Inc
44000-R
In Commercial Distribution

  • 00690455440003 ()
44000-R

  • Ozone/hydrogen peroxide sterilizer
The STERIZONE® CI+ Chemical Indicator (CI+) is a Type 1 (Class 1) process indicator, which distinguishes between processed and unprocessed medical device packages, intended for sterilization using the STERIZONE® VP4 Sterilizer.
TSO3 Inc
43810-1
In Commercial Distribution

  • 00690455438109 ()
  • 00690455438116 ()
43810-1

  • Chemical/physical sterilization process indicator
The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) (Figure 1) is a self-contained stand-alone biological monitor intended to provide users with a means to assess spore kill by the vaporized 125-280 Solution™ (50 wt% hydrogen peroxide) injected in the STERIZONE® VP4 Sterilizer.
TSO3 Inc
42602-1
In Commercial Distribution

  • 00690455426021 ()
  • 00690455750218 ()
42602-1

  • Biological sterilization indicator
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500350 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500336 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500312 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500282 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500237 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500206 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500169 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500275 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500213 ()


  • Head-worn lamp
Wearable Surgical Lighting System
TAIYO CORPORATION
-H
Not in Commercial Distribution

  • 14589864500176 ()


  • Head-worn lamp
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