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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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OrthoFlex - 00190730002228

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

OrthoFlex - 00190730002204

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

OrthoFlex - 00190730002181

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

OrthoFlex - 00190730002167

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

OrthoFlex - 00190730002150

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

OrthoFlex - 00190730002143

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

OrthoFlex - 00190730002112

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

OrthoFlex - 00190730002105

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

OrthoFlex - 00190730001849

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

OrthoFlex - 00190730001825

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

OrthoFlex - 00190730001801

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

OrthoFlex - 00190730001788

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 - 00190730000651

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 SCom. Recording-/CARTO® Cable - 04260166371352

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-SCom. Recording-/CARTO® Cable - 04260166371345

SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 15 m
Stockert GmbH
M490023
In Commercial Distribution

  • 04260166371345 ()


  • Electrical-only medical device connection cable, reusable

THC CONTROL 2 - 05055273207965

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

THC CONTROL 1 - 05055273207958

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

Atellica CH Thc - 00630414596099

Cannabinoids (Thc) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097503
In Commercial Distribution

  • 00630414596099 ()
11097503

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

HairCheck-DT (THC) Exempt - 00868586000261

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)

CEDIA Multi-Level THC - 00884883004115

No Description
Microgenics Corporation
1661256
In Commercial Distribution

  • 00884883004115 ()


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

THC TEST STRIP - 06970429843127

No Description
Co-Innovation Biotech Co., Ltd
THC3.5
Not in Commercial Distribution

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


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

DrugSmart Dip - 00859144006252

COC/MET1000/OPI300/THC DipCard
Twin Spirit Inc.
30413D
Not in Commercial Distribution

  • 00859144006252 ()
30413D

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

ImmuTest Drugs of Abuse Screen Card - 00816565021271

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

Wondfo Drug Test Cassette - 00816862025835

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

Wondfo Drug Test Dip Card - 00816862025828

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

Wondfo Drug Test Dip Card - 00816862025552

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

Wondfo Drug Test Dip Card - 00816862020823

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

Wondfo Drug Test Dip Card - 00816862020557

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

Wondfo Drug Test Cassette - 00816862020830

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

Marijuana (THC) Urine Cassette Test - 10796918000481

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 - 10758750001804

VITROS Chemistry Products THC Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801994
In Commercial Distribution

  • 10758750001804 ()
  • 20758750001801 ()
6801994

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

iCassette™ - 00817405022557

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™ - 00817405022311

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

Rapid ONE - 10694644800057

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 2nd gen. - 10694644500162

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 2nd gen. - 10694644500131

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

RDS - 10694644300540

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

Rapid TOX - 10694644100386

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

Rapid TOX - 10694644100218

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 PLUS LEVEL 4 V2 - B800THC4UV2NJSP0

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
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