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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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No Description
Izenimplant Co., Ltd.
ZGFDCSM25M
In Commercial Distribution

  • 08800070231340 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
ZGFDCSN21M
In Commercial Distribution

  • 08800070231333 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
MDRAL
In Commercial Distribution

  • 08800070231326 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
MDRAS
In Commercial Distribution

  • 08800070231319 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
MDCAL
In Commercial Distribution

  • 08800070231302 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
MDCAS
In Commercial Distribution

  • 08800070231296 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Izenimplant Co., Ltd.
SD70
In Commercial Distribution

  • 08800070231289 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.
OSUNG MND Co., Ltd.
BSWDTS
In Commercial Distribution

  • 08800075621108 ()


  • Surgical screwdriver, reusable
Salvin AutoTorq® Automatic Electric Torque Driver + Charging Cradle
SALVIN DENTAL SPECIALTIES, LLC
AUTOTORQ-35
In Commercial Distribution

  • 00841336112346 ()
AUTOTORQ-35

  • Suturing needle holder, reusable
Salvin Screw Driver & Handle
SALVIN DENTAL SPECIALTIES, LLC
FIX-DRIVER
In Commercial Distribution

  • 00841336112070 ()
FIX-DRIVER

  • Suturing needle holder, reusable
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