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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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HarmonyAIR - 00724995173432

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

HarmonyAIR - 00724995173210

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

HarmonyAIR - 00724995173203

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

HarmonyAIR - 00724995173197

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

HarmonyAIR - 00724995173180

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

HarmonyAIR - 00724995173173

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

UCP Home Drug Screening Test Cups - 10817038021795

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

ProMax Surgical Gown - 00634916795493

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

Promax Backless Pathology Gown - 00634916684926

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 - 00634916684919

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 - 00634916684896

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

X-MIND trium - D804W09000560

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 - D804W09000550

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 - D804W09000110

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 - D804W09000050

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

Alere iCup Dx Pro 2 - 00817405021062

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

Solarc/SolRx 1000-Series - B2191780UVBNB230V0

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

Identify Diagnostics USA - 10850013035165

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

cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System - 00875197005950

No Description
Roche Molecular Systems, Inc.
08160104190
In Commercial Distribution

  • 00875197005950 ()
08160104190

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

cobas® Influenza A/B &RSV Quality Control Kit for use on the cobas® Liat® System - 00875197005653

No Description
Roche Molecular Systems, Inc.
07402686190
In Commercial Distribution

  • 00875197005653 ()
07402686190

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

ID NOW Influenza A & B 2 Control Swab Kit - 10811877011221

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

Alere™ i Influenza A & B Control Swab Kit - 10811877010811

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

Alere™ i Influenza A & B - 10811877010804

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)

ID NOW Influenza A & B 2 - 10811877010422

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)

Alere i Influenza A & B 2 - 10811877010019

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)

Lyra - 30014613311003

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)

HarmonyAIR - 00724995172763

The HarmonyAIR E-Series High Definition Dual Light with Single 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

  • 00724995172763 ()
LEH02NC02T

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

HarmonyAIR - 00724995172756

The HarmonyAIR E-Series High Definition Dual Light with Single 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

  • 00724995172756 ()
LEH02NC01T

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

EZ-SCREEN® CUP - 00690286000537

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Phencyclidine, Amphetamine, Benzodiazepines, Methadone, Barbiturates, Oxycodone, and Propoxyphene drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605205
In Commercial Distribution

  • 00690286000537 ()
  • 10690286000534 ()


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

EZ-SCREEN® CUP - 00690286000476

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Phencyclidine, Amphetamine, Benzodiazepines, Methadone, Barbiturates, Oxycodone, and Buprenorphine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605106
Not in Commercial Distribution

  • 00690286000476 ()
  • 10690286000473 ()


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