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 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 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
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
is a sponge for wound dressing, prepping, and scrubbing.
DISTRIBUTION UNLIMITED, LLC
1
In Commercial Distribution

  • 10850014433441 ()
  • 00850014433444 ()
  • 20850014433448 ()

  • Height: 4 Inch
  • Length: 4 Inch
DU1204

  • Non-woven gauze pad, non-sterile
The Safety Needle Cartridge is an accessory of Exceed.
MT.DERM GmbH
EMNPA4806USMP
In Commercial Distribution

  • EMTDEMNPA4806USMP0 ()


  • Cosmetic micro-needling electronic handpiece cartridge, professional
The Safety Needle Cartridge is an accessory of Exceed.
MT.DERM GmbH
EMNPA4206USMP
In Commercial Distribution

  • EMTDEMNPA4206USMP1 ()
  • EMTDEMNPA4206USMP0 ()


  • Cosmetic micro-needling electronic handpiece cartridge, professional
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
The product is used for 3D Printing dental model.
Hangzhou SHINING3D Dental Technology Co., Ltd.
W20
In Commercial Distribution

  • 06975338701674 ()


  • Dental appliance fabrication material, resin
The product is used for 3D printing denture teeth.
Hangzhou SHINING3D Dental Technology Co., Ltd.
CB20-B3
In Commercial Distribution

  • 06975338700363 ()


  • Dental appliance fabrication material, resin
The product is used for 3D printing denture teeth.
Hangzhou SHINING3D Dental Technology Co., Ltd.
CB20-B2
In Commercial Distribution

  • 06975338700356 ()


  • Dental appliance fabrication material, resin
The product is used for 3D printing denture teeth.
Hangzhou SHINING3D Dental Technology Co., Ltd.
CB20-B1
In Commercial Distribution

  • 06975338700349 ()


  • Dental appliance fabrication material, resin
The product is used for 3D printing denture teeth.
Hangzhou SHINING3D Dental Technology Co., Ltd.
CB20-A3.5
In Commercial Distribution

  • 06975338700332 ()


  • Dental appliance fabrication material, resin
The product is used for 3D printing denture teeth.
Hangzhou SHINING3D Dental Technology Co., Ltd.
CB20-A3
In Commercial Distribution

  • 06975338700325 ()


  • Dental appliance fabrication material, resin
The product is used for 3D printing denture teeth.
Hangzhou SHINING3D Dental Technology Co., Ltd.
CB20-A2
In Commercial Distribution

  • 06975338700318 ()


  • Dental appliance fabrication material, resin
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
The product is used for 3D printing denture teeth.
Hangzhou SHINING3D Dental Technology Co., Ltd.
CB11-A3.5
In Commercial Distribution

  • 06975338700233 ()


  • Dental appliance fabrication material, resin
The product is used for 3D printing denture teeth.
Hangzhou SHINING3D Dental Technology Co., Ltd.
CB11-A3
In Commercial Distribution

  • 06975338700226 ()


  • Dental appliance fabrication material, resin
The product is used for 3D printing denture teeth.
Hangzhou SHINING3D Dental Technology Co., Ltd.
CB11-A2
In Commercial Distribution

  • 06975338700219 ()


  • Dental appliance fabrication material, resin
The product is used for 3D printing denture teeth.
Hangzhou SHINING3D Dental Technology Co., Ltd.
CB11-A1
In Commercial Distribution

  • 06975338700134 ()


  • Dental appliance fabrication material, resin
Roentgen Works 6.6.0 is a PACS, RIS, and Viewer.
Brit Systems, LLC
6.6.0
In Commercial Distribution

  • 00850631008735 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software
The TriNEST™ microplate incubator and shaker is intended for use in laboratories where incubation and shaking of microplates is needed.
Wallac Oy
1296-0050
In Commercial Distribution

  • 06438147297726 ()
1296-0050

  • Laboratory shaker IVD
The Radiant Renewal Skincare Wand (Model: HD-15) is intended for treating wrinkles on the face and is indicated for over-the-counter use.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
HD-15
In Commercial Distribution

  • 00850035134368 ()


  • Cosmetic red-light phototherapy system, home-use
The material is an alternative to traditional dental prostheses material. SprintRay OnX Tough resin is intended exclusively for professional dental work.
Sprintray, Inc.
SRI-0202120
In Commercial Distribution

  • 00850039704536 ()

  • Weight: 1 Kilogram
SRI-0202120

  • Dental appliance fabrication material, resin
The material is an alternative to traditional dental prostheses material. SprintRay OnX Tough resin is intended exclusively for professional dental work.
Sprintray, Inc.
SRI-0202119
In Commercial Distribution

  • 00850039704529 ()

  • Weight: 1 Kilogram
SRI-0202119

  • Dental appliance fabrication material, resin
The material is an alternative to traditional dental prostheses material. SprintRay OnX Tough resin is intended exclusively for professional dental work.
Sprintray, Inc.
SRI-0202118
In Commercial Distribution

  • 00850039704512 ()

  • Weight: 1 Kilogram
SRI-0202118

  • Dental appliance fabrication material, resin
The material is an alternative to traditional dental prostheses material. SprintRay OnX Tough resin is intended exclusively for professional dental work.
Sprintray, Inc.
SRI-0202071
In Commercial Distribution

  • 10850039704175 ()
  • 00850039704178 ()

  • Total Volume: 1 Liter
SRI-0202071

  • Dental appliance fabrication material, resin
The material is an alternative to traditional dental prostheses material. SprintRay NightGuard Firm resin is intended exclusively for professional dental work.
Sprintray, Inc.
SRI-0202016
In Commercial Distribution

  • 10850039704168 ()
  • 00850039704161 ()

  • Total Volume: 1 Liter
SRI-0202016

  • Dental appliance fabrication material, resin
The Zap-X Radiosurgery System (“Zap-X System”) is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.
ZAP SURGICAL SYSTEMS, INC.
300150
In Commercial Distribution

  • 00860183001504 ()


  • Stereotactic radiosurgery/radiation therapy linear accelerator system
The Universal Legholder is contoured and padded for comfortable leg support, and is mounted on a ball joint for positioning flexibility.
STERIS CORPORATION
BF266
In Commercial Distribution

  • 00724995156985 ()
BF266

  • Leg procedure positioner
The swiftPro LRT applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handpiece.
EMBLATION LIMITED
SWF-AT03
In Commercial Distribution

  • 05060652910114 ()
SWF-AT03

  • Intraoperative gamma radiation detection system probe cover
The swiftPro URT applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handpiece.
EMBLATION LIMITED
SWF-AT02
In Commercial Distribution

  • 05060652910091 ()
SWF-AT02

  • Intraoperative gamma radiation detection system probe cover
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