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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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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
KIT0704
Not in Commercial Distribution

  • 03700757200766 ()
/

  • 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
KIT0703
Not in Commercial Distribution

  • 03700757200759 ()
/

  • 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
KIT0702
Not in Commercial Distribution

  • 03700757200650 ()
/

  • 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
KIT0701
Not in Commercial Distribution

  • 03700757200643 ()
/

  • Surgical implant template, single-use
It is a Wi-Fi camera with type C connection that allows the digitization of images taken on Tablets, smartphones and PCs using dedicated Apps and Software. It is compatible with most optical devices such as microscopes, endoscopes and fiberoptic endoscopes, lenses with C-mount type attachment in addition to the appropriate Couplers or adapters supplied.
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-309
Not in Commercial Distribution

  • B1621111 ()


  • Otoscope, direct
The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx is used for sequencing run setup, run monitoring, and primary analysis on the NextSeq™ 550Dx instrument for the Illumina® DNA Prep with Enrichment Dx library preparation assay. The LRM software (SW) includes the UDI information in the User Interface.
ILLUMINA, INC.
20063024
In Commercial Distribution

  • 00816270020415 ()
20063024

  • Nucleic acid sequencing reagent kit IVD
The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for MiSeq™Dx is used for sequencing run setup, run monitoring, and primary analysis on the MiSeq™Dx instrument for the Illumina® DNA Prep with Enrichment Dx library preparation assay. The LRM software (SW) includes the UDI information in the User Interface.
ILLUMINA, INC.
20063022
In Commercial Distribution

  • 00816270020392 ()
20063022

  • Nucleic acid sequencing reagent kit IVD
AccuTab is a tablet with associated software (AccuData) that connects to the Accuryn Monitor. The tablet is an extension of the Accuryn Monitor and only displays the data that already exists on the Accuryn Monitor. AccuTab with AccuData is solely intended to transfer, store, convert forms, and display medical device data from the Accuryn Monitor.
POTRERO MEDICAL, INC.
FGN-06-101581
In Commercial Distribution

  • 00850019755015 ()
FGN-06-101581

  • Multi-parameter urinary monitoring system control unit
The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles by preserving hair integrity (amount of hair per follicle and hair quality) for further hair graft implantation. This is done by optimizing hair transplant for both the receiver (increasing quality of the recipient area with respect to naturalness and density) and the donor (taking care of the donor region). The WAW Duo FUE System is composed of the following: - The WAW Wireless Handpiece: o Composed of a motor and a battery, and a detachable cleanable (via autoclave) external sleeve o Connected via Bluetooth to the tablet o Responsible for the rotation and oscillation movements of the punch (not included) for the FUE, - The WAW Wired Handpiece, a backup solution for the WAW Wireless Handpiece: o Cleanable (via autoclave) o Connected via a wire to the pedal o Responsible for the rotation and oscillation movements of the punch for the FUE, - The WAW Pedal, responsible for activating the handpieces, - The WAW Software, responsible for defining the parameters of functioning (rotation and oscillation movement) of the handpieces and mode (manual, semi-auto, auto or continuous) of the pedal (the Samsung tablet is supplied), - The WAW Charging Station, intended to recharge the wireless handpiece and - The External Sleeve Support Box, intended to sustain external parts of WAW Wireless Handpiece and WAW Wired Handpiece during autoclave process. - Assembly tools: 3 mounting tools to assemble and disassemble the handpieces.
Devroye Instruments Belgium
1
In Commercial Distribution

  • 05430003362228 ()


  • Electrosurgical handpiece, reusable
The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles by preserving hair integrity (amount of hair per follicle and hair quality) for further hair graft implantation. This is done by optimizing hair transplant for both the receiver (increasing quality of the recipient area with respect to naturalness and density) and the donor (taking care of the donor region). The WAW Duo FUE System is composed of the following: - The WAW Wireless Handpiece: o Composed of a motor and a battery, and a detachable cleanable (via autoclave) external sleeve o Connected via Bluetooth to the tablet o Responsible for the rotation and oscillation movements of the punch (not included) for the FUE, - The WAW Wired Handpiece, a backup solution for the WAW Wireless Handpiece: o Cleanable (via autoclave) o Connected via a wire to the pedal o Responsible for the rotation and oscillation movements of the punch for the FUE, - The WAW Pedal, responsible for activating the handpieces, - The WAW Software, responsible for defining the parameters of functioning (rotation and oscillation movement) of the handpieces and mode (manual, semi-auto, auto or continuous) of the pedal (the Samsung tablet is supplied), - The WAW Charging Station, intended to recharge the wireless handpiece and - The External Sleeve Support Box, intended to sustain external parts of WAW Wireless Handpiece and WAW Wired Handpiece during autoclave process. - Assembly tools: 3 mounting tools to assemble and disassemble the handpieces.
Devroye Instruments Belgium
1
In Commercial Distribution

  • 05430003362051 ()


  • Electrosurgical handpiece, reusable
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