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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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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
The Viper cortical titanium screw, which is placed proximally.
Ascension Orthopedics, Inc.
28135018
Not in Commercial Distribution

  • M248281350181 ()
  • 10381780065180 ()

  • 3.5 mm dia x 21.2 mm L; 18 mm thread
28135018

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Viper cortical titanium screw, which is placed proximally.
Ascension Orthopedics, Inc.
28135016
Not in Commercial Distribution

  • M248281350161 ()
  • 10381780065173 ()

  • 3.5 mm dia x 19.2 mm L; 16 mm thread
28135016

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Viper cortical titanium screw, which is placed proximally.
Ascension Orthopedics, Inc.
28135014
Not in Commercial Distribution

  • M248281350141 ()
  • 10381780065166 ()

  • 3.5 mm dia x 17.2 mm L; 14 mm thread
28135014

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Viper cortical titanium screw, which is placed proximally.
Ascension Orthopedics, Inc.
28135012
Not in Commercial Distribution

  • M248281350121 ()
  • 10381780065159 ()

  • 3.5 mm dia x 15.2 mm L; 12 mm thread
28135012

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Viper cortical titanium screw, which is placed proximally.
Ascension Orthopedics, Inc.
28135010
Not in Commercial Distribution

  • M248281350101 ()
  • 10381780065142 ()

  • 3.5 mm dia x 13.2 mm L; 10 mm thread
28135010

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Viper cortical titanium screw, which is placed proximally.
Ascension Orthopedics, Inc.
2813508
Not in Commercial Distribution

  • M24828135081 ()
  • 10381780065135 ()

  • 3.5mm dia x 11.2 mm L; 8 mm thread
2813508

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The clamp holder is used to grip the implant.
NEWDEAL
239500ND
Not in Commercial Distribution

  • M248239500ND1 ()
  • 10381780051923 ()


  • Surgical implant handling forceps
The Glenoid Drill Shaft is used to create holes.
Ascension Orthopedics, Inc.
DRS-0926-001
In Commercial Distribution

  • M269DRS09260011 ()
  • 10381780258308 ()


  • Surgical drill guide, reusable
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
The PowerCube Diffusion+ is equipped with the MultiX Trolley.
Ganshorn Medizin Electronic GmbH
A
Not in Commercial Distribution

  • 07613365500301 ()


  • 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
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 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
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
The product is used for 3D printing denture teeth.
Hangzhou SHINING3D Dental Technology Co., Ltd.
CB20-A1
In Commercial Distribution

  • 06975338700301 ()


  • Dental appliance fabrication material, resin
The product is used for 3D printing denture teeth.
Hangzhou SHINING3D Dental Technology Co., Ltd.
CB11-B3
In Commercial Distribution

  • 06975338700264 ()


  • Dental appliance fabrication material, resin
The product is used for 3D printing denture teeth.
Hangzhou SHINING3D Dental Technology Co., Ltd.
CB11-B2
In Commercial Distribution

  • 06975338700257 ()


  • Dental appliance fabrication material, resin
The product is used for 3D printing denture teeth.
Hangzhou SHINING3D Dental Technology Co., Ltd.
CB11-B1
In Commercial Distribution

  • 06975338700240 ()


  • Dental appliance fabrication material, resin
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