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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OrtFlx Com McLaughlin 022 UL2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-812
In Commercial Distribution

  • 00190730002228 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 022 UR2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-811
In Commercial Distribution

  • 00190730002204 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 022 UL1 Rx +17º Tor. +4º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-802
In Commercial Distribution

  • 00190730002181 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 018 LL5 Rx -17º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-774
In Commercial Distribution

  • 00190730002150 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 018 UL2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-712
In Commercial Distribution

  • 00190730001849 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 018 UR2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-711
In Commercial Distribution

  • 00190730001825 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 022 LR4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-863
In Commercial Distribution

  • 00190730002488 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 022 UR1 Rx +17º Tor. +4º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-801
In Commercial Distribution

  • 00190730002167 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 018 LR5 Rx -17º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-773
In Commercial Distribution

  • 00190730002143 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 018 LL4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-764
In Commercial Distribution

  • 00190730002112 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 018 LR4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-763
In Commercial Distribution

  • 00190730002105 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 018 UL1 Rx +17º Tor. +4º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-702
In Commercial Distribution

  • 00190730001801 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 018 UR1 Rx +17º Tor. +4º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-701
In Commercial Distribution

  • 00190730001788 ()


  • Orthodontic bracket, plastic, single-use
Avalon Com McLaughlin 022 LL4 Rx -12° Tor. +2° Ang.(10PK)
ORTHO TECHNOLOGY, INC.
A22-864
Not in Commercial Distribution

  • 00190730000651 ()


  • Orthodontic bracket, plastic, single-use
SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 15 m
Stockert GmbH
M490023
In Commercial Distribution

  • 04260166371345 ()


  • Electrical-only medical device connection cable, reusable
HairCheck-DT (THC) is an ELISA test kit used for qualitative detection of THC-COOH in head hair with a cutoff of 1.0 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls.
Quest Diagnostics
PVJ-Exempt
In Commercial Distribution

  • 00868586000261 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
The Randox Cannabinoid Control - Level 2 is intended for use in the Quality Control of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay. The Cannabinoid Control Level 2 contains the specific drug Cannabinoid.
RANDOX LABORATORIES LIMITED
DA3128
In Commercial Distribution

  • 05055273207965 ()
DA3128

  • Cannabinoid/cannabinoid metabolite IVD, control
The Randox Cannabinoid Control - Level 1 is intended for use in the Quality Control of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay. The Cannabinoid Control Level 1 contains the specific drug Cannabinoid.
RANDOX LABORATORIES LIMITED
DA3127
In Commercial Distribution

  • 05055273207958 ()
DA3127

  • Cannabinoid/cannabinoid metabolite IVD, control
Cannabinoids (Thc) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097503
In Commercial Distribution

  • 00630414596099 ()
11097503

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
Microgenics Corporation
1661256
In Commercial Distribution

  • 00884883004115 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
Co-Innovation Biotech Co., Ltd
THC3.5
Not in Commercial Distribution

  • 16970429843124 ()
  • 06970429843127 ()
  • 26970429843121 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
COC/MET1000/OPI300/THC DipCard
Twin Spirit Inc.
30413D
Not in Commercial Distribution

  • 00859144006252 ()
30413D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 03 COC150/THC/MOP300
REDWOOD TOXICOLOGY LABORATORY, INC.
011020194
In Commercial Distribution

  • 10858904006560 ()
  • 00858904006563 ()
DOA-134-951

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 03 COC150/MAMP500/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020193
In Commercial Distribution

  • 10858904006553 ()
  • 00858904006556 ()
DOA-134-571

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 3 COC/M-AMP/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020009
In Commercial Distribution

  • 10858904006201 ()
  • 00858904006204 ()
DOA-234-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 3 COC/THC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020010
In Commercial Distribution

  • 10858904006195 ()
  • 00858904006198 ()
DOA-434-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 3 M-AMP/THC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020011
In Commercial Distribution

  • 10858904006188 ()
  • 00858904006181 ()
DOA-334-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
VITROS Chemistry Products THC Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801994
In Commercial Distribution

  • 10758750001804 ()
  • 20758750001801 ()
6801994

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Marijuana (THC) Urine Cassette Test
ALFA SCIENTIFIC DESIGNS, INC.
03-3082
In Commercial Distribution

  • 10796918000481 ()
  • 00796918000484 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
RapidTOX THC single 50/case
AMERICAN BIO MEDICA CORPORATION
10-THCT-000
In Commercial Distribution

  • 10694644100386 ()
  • 10694644150381 ()
10-THCT-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RAPIDTOX CASSETTE WITH THC/COC
AMERICAN BIO MEDICA CORPORATION
10-8XCT-030
In Commercial Distribution

  • 10694644100218 ()
  • 10694644150213 ()
10-8XCT-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
THC pouched strip 100/box
AMERICAN BIO MEDICA CORPORATION
10-THCS-000
In Commercial Distribution

  • 10694644800057 ()
  • 10694644850052 ()
10-THCS-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RTCII MINI THC/COC150/METH500/
AMERICAN BIO MEDICA CORPORATION
10-9ZOX3-030
Not in Commercial Distribution

  • 10694644500162 ()
  • 10694644550167 ()
10-9ZOX3-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RTCII MINICUP THC/COC150/METH5
AMERICAN BIO MEDICA CORPORATION
10-8MOX3-030
Not in Commercial Distribution

  • 10694644500131 ()
  • 10694644550136 ()
10-8MOX3-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
7Pan bulk w/6SP + THC
AMERICAN BIO MEDICA CORPORATION
10-7SPB-257
In Commercial Distribution

  • 10694644300540 ()
  • 10694644350545 ()
10-7SPB-257

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
THC PLUS LEVEL 4 V2
UTAK LABORATORIES, INC.
THC+ 4 U V2 NJSP
In Commercial Distribution

  • B800THC4UV2NJSP5 ()
  • B800THC4UV2NJSP0 ()

  • Total Volume: 5 Milliliter
THC+ 4 U V2 NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 3 V2
UTAK LABORATORIES, INC.
THC+ 3 U V2 NJSP
In Commercial Distribution

  • B800THC3UV2NJSP5 ()
  • B800THC3UV2NJSP0 ()

  • Total Volume: 5 Milliliter
THC+ 3 U V2 NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
AMP/COC/MET/MOR/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP05021 ()
  • B115ABCUP05020 ()
ABCup-05-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/OPI2000/PCP/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD05091 ()
  • B115ABCARD05090 ()
ABCard-05-09

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

  • B115ABCARD05071 ()
  • B115ABCARD05070 ()
ABCard-05-07

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