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 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
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
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
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 T1 4°
In Commercial Distribution

  • 07640167930265 ()
GT102000S

  • Vertebral body prosthesis
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
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
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
Mixing Tip/ Intraoral Tip is the mixing and application device to be applied with AH Plus Jet and is available seperately
Dentsply De Trey GmbH
60620116
In Commercial Distribution

  • D01060620110 ()
  • D01060620111 ()

  • Length: 5.2 Centimeter
60620116

  • Endodontic filling/sealing material
Protective cover is placed on a flat panel sensor (DR-ID 1836SE) during recumbent exposure and is covered to reinforce the strength.
FUJIFILM CORPORATION
DR1836 SE PROTECTIVE COVER E
In Commercial Distribution

  • 04547410483437 ()

  • 470x860x25mm


  • Stationary basic diagnostic x-ray system, digital
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
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
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW02NA0050
In Commercial Distribution

  • 09421906017977 ()

  • Weight: 50 Milligram


  • Animal-derived wound matrix dressing
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW02NA0100
In Commercial Distribution

  • 09421906017960 ()

  • Weight: 100 Milligram


  • Animal-derived wound matrix dressing
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW02NA0200
In Commercial Distribution

  • 09421906017953 ()

  • Weight: 200 Milligram


  • Animal-derived wound matrix dressing
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW02NA0500
In Commercial Distribution

  • 09421906017946 ()

  • Weight: 500 Milligram


  • Animal-derived wound matrix dressing
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW02NA1000
In Commercial Distribution

  • 09421906017939 ()

  • Weight: 1000 Milligram


  • Animal-derived wound matrix dressing
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW02NA2000
Not in Commercial Distribution

  • 09421906017922 ()

  • Weight: 2000 Milligram


  • Animal-derived wound matrix dressing
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW01NA2000
Not in Commercial Distribution

  • 09421906017915 ()

  • Weight: 2000 Milligram


  • Animal-derived wound matrix dressing
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW01NA1000
In Commercial Distribution

  • 09421905067928 ()

  • Weight: 1000 Milligram


  • Animal-derived wound matrix dressing
Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
AROA BIOSURGERY LIMITED
PW01NA0500
In Commercial Distribution

  • 09421905067911 ()

  • Weight: 500 Milligram


  • Animal-derived wound matrix dressing
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 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
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