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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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NobelActive®/NobelParallel™ CC PureSet Plate
Nobel Biocare AB
PUR0201
In Commercial Distribution

  • 07332747150001 ()

  • Length: 260.000 Millimeter
  • Height: 1.500 Millimeter
  • Width: 165.000 Millimeter
PUR0201

  • Instrument tray, reusable
NobelActive®/NobelParallel™ CC PureSet Tray
Nobel Biocare AB
PUR0200
In Commercial Distribution

  • 07332747149975 ()

  • Height: 47.000 Millimeter
  • Length: 276.100 Millimeter
  • Width: 176.000 Millimeter
PUR0200

  • Instrument tray, reusable
Temporary Snap Abutment Engaging CC WP 3mm
Nobel Biocare AB
38849
In Commercial Distribution

  • 07332747115680 ()

  • Height: 3.000 Millimeter
38849

  • Dental implant suprastructure, temporary, preformed, single-use
Temporary Snap Abutment Engaging CC RP 3mm
Nobel Biocare AB
38848
In Commercial Distribution

  • 07332747115673 ()

  • Height: 3.000 Millimeter
38848

  • Dental implant suprastructure, temporary, preformed, single-use
Temporary Snap Abutment Engaging CC NP 3mm
Nobel Biocare AB
38847
In Commercial Distribution

  • 07332747115666 ()

  • Height: 3.000 Millimeter
38847

  • Dental implant suprastructure, temporary, preformed, single-use
Temporary Snap Abutment Engaging CC WP 1.5mm
Nobel Biocare AB
38762
In Commercial Distribution

  • 07332747115611 ()

  • Height: 1.500 Millimeter
38762

  • Dental implant suprastructure, temporary, preformed, single-use
Temporary Snap Abutment Engaging CC RP 1.5mm
Nobel Biocare AB
38761
In Commercial Distribution

  • 07332747115604 ()

  • Height: 1.500 Millimeter
38761

  • Dental implant suprastructure, temporary, preformed, single-use
Temporary Snap Abutment Engaging CC NP 1.5mm
Nobel Biocare AB
38760
In Commercial Distribution

  • 07332747113891 ()

  • Height: 1.500 Millimeter
38760

  • Dental implant suprastructure, temporary, preformed, single-use
Guided Implant Mount NobPrl CC WP 5.5
Nobel Biocare AB
38068
In Commercial Distribution

  • 07332747092738 ()

  • Outer Diameter: 5.500 Millimeter
38068

  • Surgical screwdriver, reusable
Guided Implant Mount NobPrl CC RP 5.0
Nobel Biocare AB
38067
In Commercial Distribution

  • 07332747092721 ()

  • Outer Diameter: 5.000 Millimeter
38067

  • Surgical screwdriver, reusable
Guided Implant Mount NobPrl CC RP 4.3
Nobel Biocare AB
38066
In Commercial Distribution

  • 07332747092714 ()

  • Outer Diameter: 4.300 Millimeter
38066

  • Surgical screwdriver, reusable
Guided Implant Mount NobRpl CC RP 5.0
Nobel Biocare AB
37151
In Commercial Distribution

  • 07332747069938 ()

  • Outer Diameter: 5.000 Millimeter
37151

  • Surgical screwdriver, reusable
Guided Implant Mount NobRpl CC RP 4.3
Nobel Biocare AB
37150
In Commercial Distribution

  • 07332747069921 ()

  • Outer Diameter: 4.300 Millimeter
37150

  • Surgical screwdriver, reusable
Guided Implant Mount NobRpl CC NP 3.5
Nobel Biocare AB
37149
In Commercial Distribution

  • 07332747069914 ()

  • Outer Diameter: 3.500 Millimeter
37149

  • Surgical screwdriver, reusable
Guide Pin Implant Level CC 3.0 20mm
Nobel Biocare AB
36792
Not in Commercial Distribution

  • 07332747175257 ()

  • Length: 20.000 Millimeter
36792

  • Dental implant suprastructure, temporary, preformed, reusable
SCREW 54740108540 4.75 HA MAS 8.5X40 CC
MEDTRONIC SOFAMOR DANEK, INC.
54740108540
In Commercial Distribution

  • 00763000872335 ()


  • Spinal bone screw, non-bioabsorbable
NAOS First MPJ Hemi, CC - L, 23mm
HNM TOTAL RECON LLC
HTR-01-000162
In Commercial Distribution

  • 00841742101057 ()
HTR-01-000162

  • Orthopaedic bone pin, non-bioabsorbable
NAOS First MPJ Hemi, CC - ML, 21.5mm
HNM TOTAL RECON LLC
HTR-01-491058
In Commercial Distribution

  • 00841742101040 ()
HTR-01-491058

  • Orthopaedic bone pin, non-bioabsorbable
NAOS First MPJ Hemi, CC - M, 20mm
HNM TOTAL RECON LLC
HTR-01-000961
In Commercial Distribution

  • 00841742101033 ()
HTR-01-000961

  • Orthopaedic bone pin, non-bioabsorbable
NAOS First MPJ Hemi, CC - MS, 18.5mm
HNM TOTAL RECON LLC
HTR-01-700833
In Commercial Distribution

  • 00841742101026 ()
HTR-01-700833

  • Orthopaedic bone pin, non-bioabsorbable
NAOS First MPJ Hemi, CC - S, 17mm
HNM TOTAL RECON LLC
HTR-01-000760
In Commercial Distribution

  • 00841742101019 ()
HTR-01-000760

  • Orthopaedic bone pin, non-bioabsorbable
CHECKLIST APP This app requires core.portal. The checklist app is a universal questionnaire and checklist system for collecting information during surgery. Checklists can be defined as customer-specific multilingual templates. The checklists are displayed in accordance with the language selected in the core.browser. The app generates a PDF report with the demographic patient data, information about the surgical intervention, a logo and the recorded data. The report is part of the documentation. The app does not spread the information collected.
Richard Wolf GmbH
5597706
Not in Commercial Distribution

  • 04055207070086 ()
5597706

  • Operating room audiovisual data/device management system application software
The Astroid Planning App is a cloud based software used for treatment planning of proton radiation therapy treatments.
DECIMAL, INC.
3.x
In Commercial Distribution

  • 00851147007120 ()


  • Radiation therapy software
A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025124 ()
ML-EG30001

  • Radiology information system application software
A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025100 ()
MLL-EG30001

  • Radiology information system application software
No Description
Thought Technology Ltd.
SA4515
In Commercial Distribution

  • 07540191000630 ()


  • Psychophysiological biofeedback system
Eversense NOW Remote Monitoring mobile application (iOS) is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information.
SENSEONICS, INCORPORATED
FG-5901-01-300
In Commercial Distribution

  • 00817491021267 ()
FG-5901-01-300

  • Implantable glucose monitoring system
No Description
TEKNIMED
Granules 10 cc
Not in Commercial Distribution

  • 03760177041196 ()

  • Granules
  • Pore Size: 220 Micrometer
  • Weight: 6.3 Gram
03.02.002

  • Bone matrix implant, synthetic, non-antimicrobial
No Description
SOC ETUDES RECHERCHES FABRICATION
TE607- 36 CC
In Commercial Distribution

  • 03662200019663 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
SOC ETUDES RECHERCHES FABRICATION
TE607- 32 CC
In Commercial Distribution

  • 03662200019632 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
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