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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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Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BEY, ZimVie - External Ø5.0
In Commercial Distribution

  • 05744003810079 ()
80610176

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BE4, ZimVie - External Ø4.0
In Commercial Distribution

  • 05744003810062 ()
80610175

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BEB, ZimVie - External Ø3.75
In Commercial Distribution

  • 05744003810055 ()
80610174

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BEP, ZimVie - External Ø3.25
In Commercial Distribution

  • 05744003810048 ()
80610173

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BCG, ZimVie - Certain Ø6.0
In Commercial Distribution

  • 05744003810031 ()
80610169

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BCY, ZimVie - Certain Ø5.0
In Commercial Distribution

  • 05744003810024 ()
80610168

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BCB, ZimVie - Certain Ø4.1
In Commercial Distribution

  • 05744003810017 ()
80610167

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BCP, ZimVie - Certain Ø3.4
In Commercial Distribution

  • 05744003810000 ()
80610166

  • Dental implant abutment analog, intraoral-scanning, single-use
spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software. This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience.
ONEFIT MEDICAL
KIT0706
Not in Commercial Distribution

  • 03700757200780 ()
/

  • Surgical implant template, single-use
spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software. This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience.
ONEFIT MEDICAL
KIT0705
Not in Commercial Distribution

  • 03700757200773 ()
/

  • Surgical implant template, single-use
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