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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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Opti-Free Pure Moist Multi-Purpose Disinfecting Solution Twin Pack 2 x 10 ozhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Alcon Laboratories, Inc.
OPTI-FREE PUREMOIST 2x10oz
In Commercial Distribution

  • 00300650361057 ()
  • 20300650362539 ()
  • 20300650370077 ()


  • Multi-purpose soft contact lens solution
Intense Pulsed Light handpiece 625 nm 25x13 (for Discohttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#very Pico family)
QUANTA SYSTEM SPA
OAM002020
In Commercial Distribution

  • 08059173390168 ()


  • Light-energy skin surface treatment system applicator
Orthex Half Ring110mm SBhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=draftDI&pageDataLoaded=false&pageMode=edit&deviceRecordKey=1091626#
VILEX IN TENNESSEE, INC.
C050-110
In Commercial Distribution

  • 00841731111937 ()


  • External orthopaedic fixation system, single-use
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. BLX RB-WB h5
In Commercial Distribution

  • 08059224151953 ()
002BLX5R

  • 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.IBS MEDICORE ø5 h5
In Commercial Distribution

  • 08059224200651 ()
002IB55R

  • Dental implant suprastructure, permanent, preformed
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
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
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
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