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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PRO CON PL TIB IS TR RT S1 20
Smith & Nephew, Inc.
71518116
In Commercial Distribution

  • 03596010225979 ()
71518116

  • Knee tibia prosthesis trial, reusable
PRO CON PL TIB IS TR RT S1 18
Smith & Nephew, Inc.
71518115
In Commercial Distribution

  • 03596010225962 ()
71518115

  • Knee tibia prosthesis trial, reusable
PRO CON PL TIB IS TR RT S1 16
Smith & Nephew, Inc.
71518114
In Commercial Distribution

  • 03596010225955 ()
71518114

  • Knee tibia prosthesis trial, reusable
PRO CON PL TIB IS TR RT S1 14
Smith & Nephew, Inc.
71518113
In Commercial Distribution

  • 03596010225948 ()
71518113

  • Knee tibia prosthesis trial, reusable
TOURNIK-IT is a hemostasis system used to control bleeding
FLAMOR SRL
TK-00
In Commercial Distribution

  • 08057592700025 ()


  • Venous tourniquet, reusable
Giotto Image is a conventional film-screen x-ray mammographic device.
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
GIOTTO IMAGE SRA
In Commercial Distribution

  • 18033837190117 ()
  • 08033837190110 ()

  • Height: 2240 Millimeter
  • Depth: 1140 Millimeter
  • Width: 1150 Millimeter
6702

  • Stationary mammographic x-ray system, digital
Giotto Image is a conventional film-screen x-ray mammographic device.
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
GIOTTO IMAGE M
In Commercial Distribution

  • 08033837190103 ()
  • 18033837190100 ()

  • Height: 2240 Millimeter
  • Depth: 1140 Millimeter
  • Width: 1150 Millimeter
6501

  • Stationary mammographic x-ray system, digital
The Finishing Shaper is used to shape the implant.
Ascension Orthopedics, Inc.
SHP443S
In Commercial Distribution

  • M269SHP443S1 ()
  • 10381780237181 ()

  • Size Small; .405 in dia
SHP-443-S

  • Bone cutter
The Finishing Shaper is used to shape the implant.
Ascension Orthopedics, Inc.
SHP443M
In Commercial Distribution

  • M269SHP443M1 ()
  • 10381780237174 ()

  • Size Medium; .458 in dia
SHP-443-M

  • Bone cutter
The Finishing Shaper is used to shape the implant.
Ascension Orthopedics, Inc.
SHP443L
In Commercial Distribution

  • M269SHP443L1 ()
  • 10381780237167 ()

  • Size Large; .520 in dia
SHP-443-L

  • Bone cutter
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
The Glenoid Drill Shaft is used to create holes.
Ascension Orthopedics, Inc.
DRS-0926-001
In Commercial Distribution

  • M269DRS09260011 ()
  • 10381780258308 ()


  • Surgical drill guide, reusable
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy Implant GIZA D 27 T3 4°
In Commercial Distribution

  • 07640167930319 ()
GL303000S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy Implant GIZA D 27 T2 4°
In Commercial Distribution

  • 07640167930302 ()
GL203000S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy Implant GIZA D 27 T1 4°
In Commercial Distribution

  • 07640167930296 ()
GL103000S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy Implant GIZA D 21 T3 4°
In Commercial Distribution

  • 07640167930289 ()
GT302000S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy Implant GIZA D 21 T2 4°
In Commercial Distribution

  • 07640167930272 ()
GT202000S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy Implant GIZA D 21 T1 4°
In Commercial Distribution

  • 07640167930265 ()
GT102000S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-10 Deg
In Commercial Distribution

  • 07640167930067 ()
48291437S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 2-5 Deg
In Commercial Distribution

  • 07640167930050 ()
48291432S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 Deg
In Commercial Distribution

  • 07640167930043 ()
48291427S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 Deg
In Commercial Distribution

  • 07640167930036 ()
48291422S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 Deg
In Commercial Distribution

  • 07640167930029 ()
48291485S

  • Vertebral body prosthesis
The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 2-5 Deg
In Commercial Distribution

  • 07640167930012 ()
48291482S

  • Vertebral body prosthesis
In-Line gas warmer is for use with laparoscopic insufflators
NORTHGATE TECHNOLOGIES INC.
72-00204-0
In Commercial Distribution

  • 00817183020592 ()
7209944

  • Insufflation gas conditioning system control unit
In-Line gas warmer is for use with laparoscopic insufflators
NORTHGATE TECHNOLOGIES INC.
6-810-00
In Commercial Distribution

  • 00817183020240 ()


  • Insufflation gas conditioning system control unit
In-Line gas warmer is for use with laparoscopic insufflators
NORTHGATE TECHNOLOGIES INC.
6-820-00
In Commercial Distribution

  • 00817183020233 ()


  • Insufflation gas conditioning system control unit
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
Bifix Temp is a dual-curing, composite-based temporary luting material.
VOCO GmbH
1055
In Commercial Distribution

  • E22110551 ()
1055

  • Dental composite resin
Bifix Temp is a dual-curing, composite-based temporary luting material.
VOCO GmbH
1056
In Commercial Distribution

  • E22110561 ()
1056

  • Dental composite resin
Following Device Identifier is including in this KIT: 07325710003152
Maquet Critical Care AB
6650514
In Commercial Distribution

  • 07325710000588 ()


  • Neonatal/adult intensive-care ventilator
Speech Generating Device with Eyegaze (IS 4) 12" Screen
TOBII DYNAVOX LLC
I-12+ IS4
Not in Commercial Distribution

  • 07340074600328 ()


  • Voice synthesizer/digitizer
Speech Generating Device with Eyegaze (IS 20) 15" Screen
TOBII DYNAVOX LLC
I-15+ IS20
Not in Commercial Distribution

  • 07340074600274 ()


  • Voice synthesizer/digitizer
PainShield actuator is part of the PainShield MD System.
NANOVIBRONIX INC.
3.0
In Commercial Distribution

  • 07290103421144 ()
10-600-0002

  • Physical therapy ultrasound system applicator, adhesive
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