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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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3M™ Unitek™ - 00652221114938

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

3M™ Unitek™ - 00652221114914

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

3M™ Unitek™ - 00652221081988

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 - 00190730010506

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 - 00190730010490

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 - 00190730010001

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 - 00190730009968

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 - 00190730009104

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 - 00190730009098

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 - 00190730008671

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 - 00190730008664

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 - 00190730007568

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 - 00190730007551

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 - 00190730010933

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 - 00190730010926

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 - 00190730009951

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 - 00190730008138

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 - 00190730008121

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

.decimal Astroid Planning App 3.x - 00851147007120

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 Mobile App iOS - 00817491021267

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

Resilience – By Inner Armor App iOS - 07540191000630

No Description
Thought Technology Ltd.
SA4515
In Commercial Distribution

  • 07540191000630 ()


  • Psychophysiological biofeedback system

Orpheus CAST Mobile App Android OS - 07290017025124

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

Orpheus CAST Mobile App iOS + Android - 07290017025100

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

NA - 04055207070086

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

OvuSense - 05060508530121

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

  • 05060508530121 ()


  • Thermometric fertility analyser

CipherOx CRI - 00860003025604

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

Aaris Acrylic Intraocular lens(IOL) - 00884872015894

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

DRIVEMEDICAL - 00822383135809

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

MIR - 08052990321711

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

MIR - 08052990321704

Smart Spirometer and Oximeter connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Smart One Oxi
In Commercial Distribution

  • 08052990321704 ()


  • Expiratory peak flow meter, digital
  • Pulse oximeter

FIBRIJET - 00815634020184

MANUAL ENDOSCOPIC SPRAY APP. W/MIX TIP 5MM X 40CM,11:1 RATIO
Micromedics, Inc.
SA-3667
In Commercial Distribution

  • 00815634020184 ()
  • 10815634020181 ()
  • 20815634020188 ()


  • Open-surgery adhesive/sealant applicator, dual-channel

3M™ SmartClip™ Dimpled Nitinol Classic OrthoForm™ - 00652221114990

SmartClip(TM) Dimpled Nitinol Classic OrthoForm(TM) II Square U .017x.025 U/Use 10/Pk
3M UNITEK CORPORATION
9297-707
In Commercial Distribution

  • 80652221114996 ()
  • 00652221114990 ()
9297-707

  • Orthodontic archwire

3M™ SmartClip™ Dimpled Nitinol Super-Elastic OrthoForm™ - 00652221114976

9296-913 SmartClip™ Dimpled Nitinol Super-Elastic OrthoForm™ III Ovoid U .016 U/Use 10/Pk
3M UNITEK CORPORATION
9296-913
In Commercial Distribution

  • 80652221114972 ()
  • 00652221114976 ()
9296-913

  • Orthodontic archwire

3M™ SmartClip™ Dimpled Nitinol Super-Elastic OrthoForm™ - 00652221114839

9296-405 SmartClip™ Dimpled Nitinol Classic OrthoForm™ II Square U .014 U/Use 10/Pk
3M UNITEK CORPORATION
9296-405
In Commercial Distribution

  • 80652221114835 ()
  • 00652221114839 ()
9296-405

  • Orthodontic archwire

3M™ SmartClip™ - 00652221114099

SmartClip(TM) Dimpled Nitinol Classic OrthoForm(TM) III Ovoid U .014x.025 U/Use 10/Pk
3M UNITEK CORPORATION
9293-823
In Commercial Distribution

  • 80652221114095 ()
  • 00652221114099 ()
9293-823

  • Orthodontic archwire

Votion - 00190730007629

Votion 018 MC(0T) U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-21-2062
In Commercial Distribution

  • 00190730007629 ()


  • Orthodontic bracket, metal

Votion - 00190730007612

Votion 018 MC(0T) U/L 5x5 Hks 3, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-21-2061
Not in Commercial Distribution

  • 00190730007612 ()


  • Orthodontic bracket, metal

Votion - 00190730008190

Votion 022 MC(0T) U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-22-2062
In Commercial Distribution

  • 00190730008190 ()


  • Orthodontic bracket, metal

Votion - 00190730008183

Votion 022 MC(0T) U/L 5x5 Hks 3, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-22-2061
In Commercial Distribution

  • 00190730008183 ()


  • Orthodontic bracket, metal

MAJESTIC - 00731791173993

Disposable Nitrile Examination Gloves, Powder Free, 100/Box, Orange, Size Small
U. S. GLOVE CO., INC.
3277DO/ 8
In Commercial Distribution

  • 00731791173993 ()
  • 50731791173998 ()
  • 20731791173997 ()
3277DO/ 8

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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