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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Rapid Response Multi Drug Test Panel (COC/AMP/MET/THC/OPI/MDMA) - 25 tests/ kit are for qualitative detection of Amphetamine, Methamphetamine, Opiates, 3,4-Methyoxydiene-Methamphetamine, Cocaine and THC metabolites in urine.
BTNX Inc
D6.14-1P29-25
In Commercial Distribution

  • 00722066003459 ()
  • 00722066004012 ()
D6.14-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The HarmonyAIR Single High Definition Light 35-inch with Single Flat Panel Monitor, No Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173432 ()
LEH04NCND

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light 43-inch with Single Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173210 ()
LEH24IN02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light 43-inch with Single Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173203 ()
LEH24IN01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light 43-inchwith Single Flat Panel Monitor, No Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173197 ()
LEH24NCND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light 43-inchwith Single Flat Panel Monitor, 20-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173180 ()
LEH24NC02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light 43-inchwith Single Flat Panel Monitor, 13-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173173 ()
LEH24NC01

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
"Keypoint Focus Workstation, DAN Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072143
Not in Commercial Distribution

  • 05704736017794 ()


  • Electromyograph
"Keypoint Focus Workstation, ITA Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072106
Not in Commercial Distribution

  • 05704736017282 ()


  • Electromyograph
"Keypoint Focus Workstation, NLD Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072105
Not in Commercial Distribution

  • 05704736017275 ()


  • Electromyograph
"Keypoint Focus Workstation, SPA Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072104
Not in Commercial Distribution

  • 05704736017268 ()


  • Electromyograph
"Keypoint Focus Workstation, DEU Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A072103
Not in Commercial Distribution

  • 05704736017251 ()


  • Electromyograph
"Keypoint Focus Workstation, ENG Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Cart with isolating power supply - System kit"
Alpine Biomed ApS
9033A0721BV
Not in Commercial Distribution

  • 05704736017206 ()


  • Electromyograph
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Phencyclidine, Amphetamine, Benzodiazepines, Methadone, Barbiturates, and Oxycodone drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605204
In Commercial Distribution

  • 00690286000520 ()
  • 10690286000527 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601673
In Commercial Distribution

  • 00690286000308 ()
  • 10690286000305 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Methadone, Barbiturates, and Oxycodone drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
604028
In Commercial Distribution

  • 10690286000053 ()
  • 00690286000056 ()


  • Multiplex analyser IVD, laboratory
  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Promax Backless Pathology Gown, 1-Ply Front Aqua ProMax, 2-Ply Aqua ProMax Sleeves, 1-Ply Aqua MLR Panel with Negastat Backs, Color Coded Tie Closures at Neck & Waist, Poly Cuffs, Size X-Large
STANDARD TEXTILE CO., INC.
75674164
In Commercial Distribution

  • 00634916684926 ()
  • 10634916684923 ()
75674164

  • Surgical gown, reusable
Promax Backless Pathology Gown, 1-Ply Front Aqua ProMax, 2-Ply Aqua ProMax Sleeves, 1-Ply Aqua MLR Panel with Negastat Backs, Color Coded Tie Closures at Neck & Waist, Poly Cuffs, Size Medium
STANDARD TEXTILE CO., INC.
75674166
Not in Commercial Distribution

  • 00634916684919 ()
  • 10634916684916 ()
75674166

  • Surgical gown, reusable
Promax Backless Pathology Gown, 1-Ply Front Aqua ProMax, 2-Ply Aqua ProMax Sleeves, 1-Ply Aqua MLR Panel with Negastat Backs, Color Coded Tie Closures at Neck & Waist, Poly Cuffs, Size Small
STANDARD TEXTILE CO., INC.
75674167
Not in Commercial Distribution

  • 00634916684896 ()
  • 10634916684893 ()
75674167

  • Surgical gown, reusable
ProMax Surgical Gown, MLR Front Yoke, Comfort Panel Back with Negastat, Snap Closures at Neck, Tape Tie Closures at Waist, With QCM, Circumferentially Offset Sleeves, Double-needle Flat Felled Chainstitch Construction
STANDARD TEXTILE CO., INC.
75614905
In Commercial Distribution

  • 00634916795493 ()


  • Surgical gown, reusable
Identify Diagnostics USA 9 Panel Drug Test Cup w/ Adulterations CLIA Waived MADE IN USA AMP500, BAR300, BUP10, BZO300, COC150, MET500, MTD300, MOP300, OXY100, (pH, SG, CR) 25 tests/box
MEDICAL DISTRIBUTION GROUP INC
ID-US9-ADULT-2
In Commercial Distribution

  • 00850013035168 ()
  • 10850013035165 ()
ID-US9-ADULT-2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
X-MIND trium PAN CBCT version including one PAN sensor,with control panel on the left side including one removable ceph sensor configurated for installation of ceph arm on the right
DE GÖTZEN SRL
XMT PAN 3D L CEPH READY R (PAN SENSOR)
Not in Commercial Distribution

  • D804W09000560 ()
W0900056

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN CBCT version including one PAN sensor,with control panel on the right side including one removable ceph sensor configurated for installation of ceph arm on the left
DE GÖTZEN SRL
XMT PAN 3D R CEPH READY L (PAN SENSOR)
Not in Commercial Distribution

  • D804W09000550 ()
W0900055

  • Stationary panoramic/tomographic dental x-ray system, digital
  • Cone beam computed tomography system, head/neck
X-MIND trium PAN CBCT version including one CEPH sensor,with control panel on the left side including one removable ceph sensor configurated for installation of ceph arm on the right
DE GÖTZEN SRL
XMT PAN 3D L CEPH READY R
Not in Commercial Distribution

  • D804W09000110 ()
W0900011

  • Stationary panoramic/tomographic dental x-ray system, digital
  • Cone beam computed tomography system, head/neck
X-MIND trium PAN CBCT version including one CEPH sensor,with control panel on the right side including one removable ceph sensor configurated for installation of ceph arm on the left
DE GÖTZEN SRL
XMT PAN 3D R CEPH READY L
Not in Commercial Distribution

  • D804W09000050 ()
W0900005

  • Stationary panoramic/tomographic dental x-ray system, digital
  • Cone beam computed tomography system, head/neck
UCP Home Drug Screening Test Cups 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/PCP/AMP/BUP with Adulteration strip (S.G./CRE/pH)
UCP BIOSCIENCES, INC.
U-DUD-8124-RCN
In Commercial Distribution

  • 20817038021792 ()
  • 10817038021795 ()
  • 00817038021798 ()
U-DUD-8124-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR, NI, OX, pH, SG) 10 Panel Drug Screen for AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, OXY100, THC50
Instant Technologies, Inc.
I-DXP-10
In Commercial Distribution

  • 00817405021062 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 8-BULB UVB-Narrowband Full Body Panel. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema). For use with 220 to 240 volt supply power.
Solarc Systems Inc
1780UVB-NB-230V
In Commercial Distribution

  • B2191780UVBNB230V0 ()


  • Ultraviolet phototherapy unit, professional
  • Ultraviolet phototherapy unit, home-use
No Description
Roche Molecular Systems, Inc.
08160104190
In Commercial Distribution

  • 00875197005950 ()
08160104190

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
07402686190
In Commercial Distribution

  • 00875197005653 ()
07402686190

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Control Swabs intended for use only with the ID NOW Influenza A & B 2 product.
Alere Scarborough, Inc.
425-080
In Commercial Distribution

  • 10811877011221 ()


  • Influenza A/B virus nucleic acid IVD, control
A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
427-000
Not in Commercial Distribution

  • 10811877010019 ()


  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Control Swabs intended for use only with the Alere i Inuenza A & B product.
Alere Scarborough, Inc.
425-080
Not in Commercial Distribution

  • 10811877010811 ()


  • Influenza A/B virus nucleic acid IVD, control
A rapid, automated, molecular test for the qualitative detection of inuenza A and B viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
425-024
Not in Commercial Distribution

  • 10811877010804 ()


  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
427-000
In Commercial Distribution

  • 10811877010422 ()


  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Lyra FLU A+B Assay
DIAGNOSTIC HYBRIDS, INC.
M100
In Commercial Distribution

  • 30014613311003 ()
M100

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The HarmonyAIR Hybrid High Definition Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176129 ()
LEH56NC02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Hybrid High Definition Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176112 ()
LEH56NC01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, No Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175771 ()
LEH13NCNDT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, No Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175535 ()
LEH11NCNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
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