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

  • D7641000054201 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S0 SENSOR SHIP KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005418
In Commercial Distribution

  • D7641000054181 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S1 SENSOR SHIP KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005411
In Commercial Distribution

  • D7641000054111 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S2 SENSOR SHIP KIT, .9M/3FT
SIRONA DENTAL, INC.
100005393
In Commercial Distribution

  • D7641000053931 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S2 SENSOR SHIP KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005391
In Commercial Distribution

  • D7641000053911 ()


  • Dental digital imaging sensor, intraoral
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
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 (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
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)
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® 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
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)
Sterile Labels - Sterile Labels - Liquid Medicines, 10 labels per panel, 2 panels per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-113
Not in Commercial Distribution

  • 00849771032915 ()
  • 00849771032908 ()
  • 00849771044055 ()
SL-113

  • Procedural medication labelling set
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 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 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
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
The HarmonyAIR E-Series Spindle Dual Light Single Flat Panel Monitor High Density is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170837 ()
LEH000001

  • Medical monitor/light mount
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
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

  • 00724995165642 ()
LM04N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series Spindle Single Light Single Flat Panel Monitor High Density is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170868 ()
LEH000004

  • Medical monitor/light mount
The HarmonyAIR E-Series Spindle Single Light Single Flat Panel Monitor High Density is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170851 ()
LEH000003

  • Medical monitor/light mount
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
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
The Single Flat Panel Monitor, Light Head with Video-G Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995166717 ()
LGH00036

  • Medical monitor/light mount
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
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
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
The Dual 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

  • 00724995165611 ()
LM02N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The 1 Box Touch Panel Control Unit Power Supply M-Series is used with the HarmonyAIR M-Series Suspension System.
STERIS CORPORATION
M-Series Suspension
In Commercial Distribution

  • 00724995165543 ()
LM0016

  • Medical monitor/light mount
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