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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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NovoFine® 32G Tip is a sterile disposable needle.
NOVO NORDISK INC.
185189
In Commercial Distribution

  • 30301691851898 ()
  • 00301691851897 ()
  • 05712249050108 ()

  • Length: 6 Millimeter
  • Needle Gauge: 32 Gauge
185189

  • Autoinjector needle
Device is a stool collection kit for at-home use.
Geneoscopy, Inc.
0
In Commercial Distribution

  • 00198715728941 ()


  • Faecal specimen collection kit IVD, home-use
I5 Exhaust Condenser (when no vent connection is available)
SKYTRON LLC
I5-CON
In Commercial Distribution

  • 10841736100483 ()
I5-CON

  • Surgical instrument washer/disinfector (chemical/thermal)
Re-order number 5808 is a case of 6 kits
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5808-1
In Commercial Distribution

  • 00842430101755 ()
  • 10842430101752 ()
5808

  • Surgical linen/cushion set
This product is a replacement part for Q.C.M.Retainer W.
CHIKAMI MILTEC INC.
W-PLB50
In Commercial Distribution

  • 04570077940371 ()
  • 04570077940340 ()


  • Orthodontic retainer
The N-cuvettessegment is an consumable in the BNII system.
Siemens Healthcare Diagnostics Products GmbH
10446520
In Commercial Distribution

  • 00842768012167 ()
  • 00842768024771 ()
OVIB31

  • Nephelometry immunoassay analyser IVD
MAARC CeraSeal-B is MTA based Bio-ceramic Root Canal Sealer.
SHIVA PRODUCTS
8501/001
In Commercial Distribution

  • 08906110440458 ()
8501/001

  • Hygroscopic dental cement
MSA is also known as Muscle Specific Actin (MSA)
BIOCARE MEDICAL LLC
CM079B
In Commercial Distribution

  • 00847627006011 ()


  • Muscle-specific alpha/gamma actin IVD, antibody
A headset that is used to measure dark adaptation.
MACULOGIX, INC.
M-1
In Commercial Distribution

  • 10850006785015 ()
  • 00850006785018 ()
  • 20850006785012 ()


  • Adaptometer
ClearUP Sinus Relief Device is a smaller package system
TIVIC HEALTH SYSTEMS INC.
SN101
In Commercial Distribution

  • 00850006251025 ()
SN101

  • Craniofacial analgesia electrical stimulator
This guide is used for the VAB type needle.
FUJIFILM CORPORATION
NEEDLE GUIDE EN E
In Commercial Distribution

  • 04547410181784 ()


  • Stationary mammographic x-ray system, digital
This guide is used for the VAB type needle.
FUJIFILM CORPORATION
NEEDLE GUIDE M/V E
In Commercial Distribution

  • 04547410143171 ()


  • Stationary mammographic x-ray system, digital
The product is used to supply power for SE.
FUJIFILM CORPORATION
DR1280 SE BATTERY E
In Commercial Distribution

  • 04547410530650 ()


  • Diagnostic x-ray digital imaging conversion system
This kit is used in combination with Mammotome Revolve.
FUJIFILM CORPORATION
LATERAL ATTACHMENT FOR M RE E
In Commercial Distribution

  • 04547410293326 ()


  • Stationary mammographic x-ray system, digital
This kit is used in combination with Mammotome Revolve.
FUJIFILM CORPORATION
ATTACHMENT FOR M RE E
In Commercial Distribution

  • 04547410293302 ()


  • Stationary mammographic x-ray system, digital
A film pack containing new films is loaded here.
FUJIFILM CORPORATION
DPX SMART TRAY : E
In Commercial Distribution

  • 04547410239355 ()


  • Diagnostic-imaging multiformat camera
IS CAN: 1KG SODA LIME ABSORBER - LOFLOSORB G/V
Intersurgical Incorporated
2198000
In Commercial Distribution

  • 05030267090273 ()
  • 05030267100187 ()


  • Carbon dioxide absorbent
IS CAN: 1KG SODA LIME ABSORBER - SPHERASORB W/V
Intersurgical Incorporated
2196000
In Commercial Distribution

  • 05030267090358 ()
  • 05030267090341 ()


  • Carbon dioxide absorbent
Exo Iris is a hand-held, general-purpose diagnostic imaging system.
Exo Imaging, Inc.
EI2001
In Commercial Distribution

  • 00850018318006 ()


  • Hand-held ultrasound imaging system, body-surface
MAGSCREEN Serenity is the remote display for MAGLIFE Serenity
SCHILLER MEDICAL
MAGSCREEN Serenity
In Commercial Distribution

  • 07613365900019 ()
1-096-9900

  • General-purpose multi-parameter bedside monitor
The PowerCube Diffusion+ is equipped with the MultiX Trolley.
Ganshorn Medizin Electronic GmbH
A
In Commercial Distribution

  • 07613365501254 ()


  • Pulmonary function analysis system, adult
Patient-Use Tubing, Do not use if package is damaged
STRYKER CORPORATION
0450000125
In Commercial Distribution

  • 37613327261036 ()
  • 07613327261035 ()
0450-000-125

  • Surgical irrigation/aspiration tubing set
The PowerCube Diffusion+ is equipped with the MultiX Trolley.
Ganshorn Medizin Electronic GmbH
A
Not in Commercial Distribution

  • 07613365500301 ()


  • Pulmonary function analysis system, adult
Bifix Temp is a dual-curing, composite-based temporary luting material.
VOCO GmbH
1056
In Commercial Distribution

  • E22110561 ()
1056

  • Dental composite resin
Bifix Temp is a dual-curing, composite-based temporary luting material.
VOCO GmbH
1055
In Commercial Distribution

  • E22110551 ()
1055

  • Dental composite resin
The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
SD1 Tower
In Commercial Distribution

  • 07630039101404 ()
19880.0005

  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
SD1 T-Top
In Commercial Distribution

  • 07630039101398 ()
21362.0102

  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
  • Dermatological extracorporeal shock wave therapy system
The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
SD1 Tower
Not in Commercial Distribution

  • 07630039101336 ()


  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
SD1 T-Top
Not in Commercial Distribution

  • 07630039101329 ()


  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
Intelect F-SW USA
In Commercial Distribution

  • 07630039101312 ()


  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
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