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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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FONA STELLARIS - D7641000055721

FONA STELLARIS S1 SENSOR BASIC KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005572
In Commercial Distribution

  • D7641000055721 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000055711

FONA STELLARIS S2 SENSOR BASIC KIT, .9M/3FT
SIRONA DENTAL, INC.
100005571
In Commercial Distribution

  • D7641000055711 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000055701

FONA STELLARIS S2 SENSOR BASIC KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005570
In Commercial Distribution

  • D7641000055701 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000055671

FONA STELLARIS S0 SENSOR BASIC KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005567
In Commercial Distribution

  • D7641000055671 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000055661

FONA STELLARIS S1 SENSOR BASIC KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005566
In Commercial Distribution

  • D7641000055661 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000055651

FONA STELLARIS S2 SENSOR BASIC KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005565
In Commercial Distribution

  • D7641000055651 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000054201

FONA STELLARIS S0 SENSOR SHIP KIT, .9M/3FT
SIRONA DENTAL, INC.
100005420
In Commercial Distribution

  • D7641000054201 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000054191

FONA STELLARIS S0 SENSOR SHIP KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005419
In Commercial Distribution

  • D7641000054191 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000054181

FONA STELLARIS S0 SENSOR SHIP KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005418
In Commercial Distribution

  • D7641000054181 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000054121

FONA STELLARIS S1 SENSOR SHIP KIT, .9M/3FT
SIRONA DENTAL, INC.
100005412
In Commercial Distribution

  • D7641000054121 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000054111

FONA STELLARIS S1 SENSOR SHIP KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005411
In Commercial Distribution

  • D7641000054111 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000054101

FONA STELLARIS S1 SENSOR SHIP KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005410
In Commercial Distribution

  • D7641000054101 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000053931

FONA STELLARIS S2 SENSOR SHIP KIT, .9M/3FT
SIRONA DENTAL, INC.
100005393
In Commercial Distribution

  • D7641000053931 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000053921

FONA STELLARIS S2 SENSOR SHIP KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005392
In Commercial Distribution

  • D7641000053921 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000053911

FONA STELLARIS S2 SENSOR SHIP KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005391
In Commercial Distribution

  • D7641000053911 ()


  • Dental digital imaging sensor, intraoral

Intra Oral Sensor - 08809460309867

Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays.
Dentium Co., Ltd
IOX2
In Commercial Distribution

  • 08809460309867 ()
IOX2

  • Dental digital imaging sensor, intraoral

Intra Oral Sensor - 08809460309850

Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays.
Dentium Co., Ltd
IOX1
In Commercial Distribution

  • 08809460309850 ()
IOX1

  • Dental digital imaging sensor, intraoral

OrthoScan Pulse Mini C-arm - B22510000004FD0

Image-intensified fluoroscopic x-ray system, mobile
Ziehm-Orthoscan, Inc.
1000-0004-FD
In Commercial Distribution

  • B22510000004FD0 ()


  • Portable general-purpose fluoroscopic x-ray system, digital

Lyra - 30014613311034

Lyra RSV+HMPV Assay
DIAGNOSTIC HYBRIDS, INC.
M103
In Commercial Distribution

  • 30014613311034 ()
M103

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Simplexa™ Flu A/B & RSV Direct Gen II - 20816101026962

No Description
DIASORIN MOLECULAR LLC
MOL2655
In Commercial Distribution

  • 20816101026962 ()
MOL2655

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Panther Fusion® - 15420045509313

Panther Fusion® Flu A/B/RSV Controls Kit.
Hologic, Inc.
FLU A B RSV CTRLS, PANTHER FUSION, IVD
In Commercial Distribution

  • 15420045509313 ()
PRD-04336

  • Multiple-genus respiratory virus nucleic acid IVD, control

Panther Fusion® - 15420045509283

The Panther Fusion® Flu A/B/RSV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV).
Hologic, Inc.
FLU A B RSV, PANTHER FUSION, 96T, IVD
In Commercial Distribution

  • 15420045509283 ()
PRD-04328

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

N/M - 00857275007797

12 panel drug test urine cup (THC/COC/MOP/AMP/MAMP/PCP/BAR/BZO/MTD/MDMA/OXY/BUP)
IDUN SOLUTIONS LLC
12511315000034
In Commercial Distribution

  • 00857275007797 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical

U-Screen - 00858998006050

U-Screen Squared Integrated CLIA Waived Cup 7 Panel Drug Screen for (THC/COC/OPI300/AMP/BUP/BZO/OXY)
Instant Tech Subsidiary Acquisition
USSCup-7BO CLIA
Not in Commercial Distribution

  • 00858998006050 ()
USSCup-7BO CLIA

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

HarmonyAIR - 00724995203221

HarmonyAIR A-Series High Density Dual Light, Dual Flat Panel Monitor is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995203221 ()
LAH14

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

HarmonyAIR - 00724995203214

HarmonyAIR E-Series High Density Dual Light, Dual Flat Panel Monitor is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Lighting System
Not in Commercial Distribution

  • 00724995203214 ()
LEH14

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

HarmonyAIR - 00724995203146

HarmonyAIR A-Series Single Adjustable Light 35-inch, Single Flat Panel Monitor is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995203146 ()
LAS04A

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

HarmonyAIR - 00724995203061

The HarmonyAIR E-Series 51-inch Auxiliary Arm, Dual Flat Panel Monitor is used with the HarmonyAIR E-Series Suspension System.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995203061 ()
LES0090

  • Medical monitor/light mount

HarmonyAIR - 00724995201012

A-Series Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995201012 ()
LAS14IN02

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

HarmonyAIR - 00724995201029

A-Series Dual Light, Dual Flat Panel Monitor, No Drop Tube is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995201029 ()
LAS14INND

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

HarmonyAIR - 00724995201005

A-Series Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995201005 ()
LAS14IN01

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

HarmonyAIR - 00724995213626

The HarmonyAIR G-Series Control Panel, Triple Light, Camera Ready G2 is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension System
In Commercial Distribution

  • 00724995213626 ()
LGH00000006V

  • Medical monitor/light mount

HarmonyAIR - 00724995213619

The HarmonyAIR G-Series Control Panel, Dual Light, Camera Ready G2 is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension System
In Commercial Distribution

  • 00724995213619 ()
LGH00000005V

  • Medical monitor/light mount

HarmonyAIR - 00724995213602

The HarmonyAIR G-Series Control Panel, Single Light, Camera Ready G2 is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension System
In Commercial Distribution

  • 00724995213602 ()
LGH00000004V

  • Medical monitor/light mount

HarmonyAIR - 00724995166502

The Single M5 without Control with Single Flat Panel Monitor is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166502 ()
LM06N

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

HarmonyAIR - 00724995166052

The Air Single M7 with Single Flat Panel Monitor Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166052 ()
LM09NT

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

HarmonyAIR - 00724995166014

The Air Dual M7/M5 with Single Flat Panel Monitor is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166014 ()
LM08N

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

HarmonyAIR - 00724995167509

The G-Series Dual Flat Panel Monitor, Spring Arm Assembly, 10065120 is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995167509 ()
LG000005

  • Medical monitor/light mount

HarmonyAIR - 00724995166991

The G5 Single No Camera Single Flat Panel Monitor Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166991 ()
LG37NT

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

HarmonyAIR - 00724995166922

The G5 Single No Camera Hybrid Single Flat Panel Monitor is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166922 ()
LG22N

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