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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 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 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
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 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 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
Case/Carton of 425 boxes of 50 TEST STRIPS HEPRO.US MM1000 - the FDA number is 3012098689 - the operator number is 10049962
HEPRO.US INC.
Hepro.usTSC
In Commercial Distribution

  • 00850578007389 ()
  • 85057800738902 ()


  • Glucose monitoring system IVD, home-use
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
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