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 LR5 Rx -17º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-873
In Commercial Distribution

  • 00190730002525 ()


  • 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 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 UL1 Rx +17º Tor. +4º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-802
In Commercial Distribution

  • 00190730002181 ()


  • 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 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 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
SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 3 m
Stockert GmbH
M490021
In Commercial Distribution

  • 04260166371352 ()


  • Electrical-only medical device connection cable, reusable
SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 15 m
Stockert GmbH
M490023
In Commercial Distribution

  • 04260166371345 ()


  • Electrical-only medical device connection cable, reusable
COC/MET1000/OPI300/THC DipCard
Twin Spirit Inc.
30413D
Not in Commercial Distribution

  • 00859144006252 ()
30413D

  • 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
COC/MET/MOR/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD05041 ()
  • B115ABCARD05040 ()
ABCard-05-04

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

  • B115ABCARD05021 ()
  • B115ABCARD05020 ()
ABCard-05-02

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

  • B115ABCARD05011 ()
  • B115ABCARD05010 ()
ABCard-05-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
iCassette THC Dev(Urine) 25T
Instant Technologies, Inc.
DTH-102
In Commercial Distribution

  • 30817405022558 ()
  • 00817405022557 ()
  • 10817405022554 ()
DTH-102

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen THC Panel(Urine) 25T
Instant Technologies, Inc.
DTH-114
In Commercial Distribution

  • 30817405022312 ()
  • 00817405022311 ()
  • 10817405022318 ()
DTH-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1-Panel Cassette; THC Marijuana/Cannabinoids
WONDFO USA CO., LTD.
WDTH-201
In Commercial Distribution

  • 00816862025835 ()
WDTH-201

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1-Panel Card; THC Marijuana/Cannabinoids
WONDFO USA CO., LTD.
WDTH-114
In Commercial Distribution

  • 00816862025828 ()
WDTH-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3-Panel Card; COC,mAMP,THC
WONDFO USA CO., LTD.
WDOA-234
In Commercial Distribution

  • 00816862025552 ()
WDOA-234

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1-Panel Cassette; THC Marijuana/Cannabinoids
WONDFO USA CO., LTD.
WDTH-201
In Commercial Distribution

  • 10816862020837 ()
  • 00816862020830 ()
  • 00816862029833 ()
WDTH-201

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1-Panel Card; THC Marijuana/Cannabinoids
WONDFO USA CO., LTD.
WDTH-114
In Commercial Distribution

  • 10816862020820 ()
  • 00816862020823 ()
  • 00816862029826 ()
WDTH-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immutest MET+THC Test Card
AMEDITECH INC.
IMD-2AMJ
Not in Commercial Distribution

  • 00816565021271 ()
IMD-2AMJ

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3-Panel Card; COC,mAMP,THC
WONDFO USA CO., LTD.
WDOA-234
In Commercial Distribution

  • 10816862020554 ()
  • 00816862020557 ()
  • 00816862029550 ()
WDOA-234

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Dip Drug Test, THC
Express Diagnostic Int'l, Inc.
30140
In Commercial Distribution

  • B2983014010 ()
30140

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Single Dip Drug Test, THC
EXPRESS DIAGNOSTICS INT'L, INC.
30140
Not in Commercial Distribution

  • B298301400 ()
30140

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

  • 10796918000481 ()
  • 00796918000484 ()


  • Cannabinoid/cannabinoid metabolite 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)
Petrolatum Gauze Non-Adhering Dressing
Derma Sciences Canada Inc
20065
In Commercial Distribution

  • 30381780491754 ()
  • 10381780491750 ()

  • 15.2 com X 91.4 cm
  • 6 in X 36 in
DKC20065

  • Petrolatum woven gauze pad
OrtFlx Com McLaughlin 022 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-841
In Commercial Distribution

  • 00190730002341 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 018 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-741
In Commercial Distribution

  • 00190730001962 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 018 U4/5 Rx -7º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-730
In Commercial Distribution

  • 00190730001924 ()


  • Orthodontic bracket, plastic, single-use
Avalon Com Roth 022 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
A22-841
In Commercial Distribution

  • 00190730000644 ()


  • Orthodontic bracket, plastic, single-use
Avalon Com Roth 018 L1/2 Rx -6° Tor. 0° Ang.(10PK)
ORTHO TECHNOLOGY, INC.
A18-741
Not in Commercial Distribution

  • 00190730000460 ()


  • Orthodontic bracket, plastic, single-use
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