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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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U OF L HICKMAN CATHETER PACK
MEDLINE INDUSTRIES, INC.
DYNJ83920C
In Commercial Distribution

  • 40198459428693 ()
  • 10198459428692 ()
DYNJ83920C

  • General surgical procedure kit, non-medicated, single-use
SmartClip(TM) Dimpled Nitinol Super-Elastic OrthoForm(TM) II Square U .016 U/Use 10/Pk
3M UNITEK CORPORATION
9296-807
In Commercial Distribution

  • 80652221114934 ()
  • 00652221114938 ()
9296-807

  • Orthodontic archwire
SmartClip(TM) Dimpled Nitinol Super-Elastic OrthoForm(TM) II Square U .014 U/Use 10/Pk
3M UNITEK CORPORATION
9296-805
In Commercial Distribution

  • 80652221114910 ()
  • 00652221114914 ()
9296-805

  • Orthodontic archwire
Unitek(TM) Permachrome Standard Stainless Steel Standard Form U .016x.022 U/Use 50/Pk
3M UNITEK CORPORATION
4300-171
In Commercial Distribution

  • 80652221081984 ()
  • 00652221081988 ()
4300-171

  • Orthodontic archwire
Pinnacle 018 Roth U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
360-91-2031
In Commercial Distribution

  • 00190730010506 ()


  • Orthodontic bracket, metal
Pinnacle 018 Roth U/L 5x5 Hks 3, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
360-91-2030
In Commercial Distribution

  • 00190730010490 ()


  • Orthodontic bracket, metal
Pinnacle 022 MC(0T) U/L 5x5 SPK, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
360-22-2060
Not in Commercial Distribution

  • 00190730010001 ()


  • Orthodontic bracket, metal
Pinnacle 022 MC U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
360-22-2031
In Commercial Distribution

  • 00190730009968 ()


  • Orthodontic bracket, metal
Votion 022 Roth U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-92-2031
In Commercial Distribution

  • 00190730009104 ()


  • Orthodontic bracket, metal
Votion 022 Roth U/L 5x5 Hks 3, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-92-2030
In Commercial Distribution

  • 00190730009098 ()


  • Orthodontic bracket, metal
Votion 018 Roth U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-91-2031
In Commercial Distribution

  • 00190730008671 ()


  • Orthodontic bracket, metal
Votion 018 Roth U/L 5x5 Hks 3, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-91-2030
In Commercial Distribution

  • 00190730008664 ()


  • Orthodontic bracket, metal
Votion 018 MC U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-21-2031
In Commercial Distribution

  • 00190730007568 ()


  • Orthodontic bracket, metal
Votion 018 MC U/L 5x5 Hks 3, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-21-2030
Not in Commercial Distribution

  • 00190730007551 ()


  • Orthodontic bracket, metal
Pinnacle 022 Roth U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
360-92-2031
In Commercial Distribution

  • 00190730010933 ()


  • Orthodontic bracket, metal
Pinnacle 022 Roth U/L 5x5 Hks 3, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
360-92-2030
In Commercial Distribution

  • 00190730010926 ()


  • Orthodontic bracket, metal
Pinnacle 022 MC U/L 5x5 Hks 3, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
360-22-2030
In Commercial Distribution

  • 00190730009951 ()


  • Orthodontic bracket, metal
Votion 022 MC U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-22-2031
In Commercial Distribution

  • 00190730008138 ()


  • Orthodontic bracket, metal
Votion 022 MC U/L 5x5 Hks 3, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-22-2030
In Commercial Distribution

  • 00190730008121 ()


  • Orthodontic bracket, metal
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
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
Thought Technology Ltd.
SA4515
In Commercial Distribution

  • 07540191000630 ()


  • Psychophysiological biofeedback system
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
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
M400 OvuFirst Starter Pack - M426 OvuFirst Skin Worn Sensor and M032 OvuSense App
VIO HEALTHTECH LIMITED
M400
In Commercial Distribution

  • 05060508530121 ()


  • Thermometric fertility analyser
The CRI app provides the patient's individual-specific measure of the Compensatory Reserve Index.
FLASHBACK TECHNOLOGIES, INC.
CRI
In Commercial Distribution

  • 00860003025604 ()


  • Pulse oximeter probe, single-use
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageDataLoaded=false&pageMode=edit&deviceRecordKey=30865#
Aaren Scientific Inc.
EC-3
In Commercial Distribution

  • 00884872015894 ()


  • Posterior-chamber intraocular lens, pseudophakic
Pressure PreventionGroup 1 Surfaces Product Description: APP Sys,Dlx,Variable Pressure,1/ea
Drive Devilbiss Healthcare
14001E
In Commercial Distribution

  • 00822383135809 ()
  • 50822383135804 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system
Smart Spirometer and Oximeter connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Spirobank Oxi
In Commercial Distribution

  • 08052990321711 ()


  • Expiratory peak flow meter, digital
  • Pulse oximeter
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