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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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Touchscreen tablet computer configured with Nova-Link app for use with OtoNova Pro. Android/Windows/iPadOS as per customer requirement.
OTODYNAMICS LIMITED
NOVA-TABLET
In Commercial Distribution

  • 05060396171512 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
Mobile app for recording breath sounds and snoring during sleep, along with file transfer from Bluetooth sleep recording devices
ENSODATA, INC.
8.0
In Commercial Distribution

  • 00864458000452 ()


  • Sleep disorder interpretive software, professional-only
Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
SET S.BLOCK N.IBS MEDICORE ø5 h5
In Commercial Distribution

  • 08059224200651 ()
002IB55R

  • Dental implant suprastructure, permanent, preformed
Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
SET S.BLOCK N. BLX RB-WB h5
In Commercial Distribution

  • 08059224151953 ()
002BLX5R

  • Dental implant suprastructure, permanent, preformed
NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
S.B.M
NON STERILE Screw for OTIS-C PLUS plate fixation
Not in Commercial Distribution

  • 03760154004152 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 70 Millimeter
EVONS66070

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageSize=25&pageMode=read+only&currentPage=0&deviceRecordKey=141332#
BEST MEDICAL INTERNATIONAL, INC.
1164-1-40
In Commercial Distribution

  • 00841365115394 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
A convenience kit consisting of 15 Digital Ovulation Tests, Digital Basal Thermometer and 3 month subscription to Natural Cycles app
SPD SWISS PRECISION DIAGNOSTICS GMBH
Birth Control Kit
In Commercial Distribution

  • 10633472602372 ()
  • 00633472602375 ()
N/A

  • Natural conception assistance kit
The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Canary Medical USA LLC
43-5570-002-14
In Commercial Distribution

  • 00860003118313 ()


  • Medical networking interface unit
The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
Samsung Electronics Co., Ltd.
1.3
In Commercial Distribution

  • 08806094948240 ()


  • Self-care monitoring/reporting software
The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
Samsung Electronics Co., Ltd.
1.3
In Commercial Distribution

  • 08806094948233 ()


  • Self-care monitoring/reporting software
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