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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https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-455T55
In Commercial Distribution

  • 08057432564695 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CEREC® Essentials with Celtra® Chairside Consumables Kit
DENTSPLY INTERNATIONAL INC.
61N002
Not in Commercial Distribution

  • D00261N0021 ()

  • 12 Blocks, 3 Firing Pads, 1 Syr. Calibra Ceram w/10 mix tips, 1 bottle Prime&Bond elect, 25 flocked app. tips, 1 disp. well, 1 syr. Coupling Agent w/25 disp. app. needles, 1 Stain & Glaze Kit
61N002

  • Dental appliance fabrication material, ceramic
Pressure PreventionGroup 1 Surfaces Product Description: Dlx APP w/Pad w/End Flaps,1/CV, 6/CT
Drive Devilbiss Healthcare
14001EFD
In Commercial Distribution

  • 00822383145457 ()
  • 50822383145452 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system
Pressure PreventionGroup 1 Surfaces Product Description: Enf.,Dlx APP w/Pad w/End Flaps,1/ea, RTL
Drive Devilbiss Healthcare
E-14001EFD
In Commercial Distribution

  • 50822383524530 ()
  • 00822383524535 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
1.5 mm x 14.0 mm self-tapping titanium alloy bone fixation screwhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Osteogenics Biomedical Inc
PFB14
In Commercial Distribution

  • D765PFB140 ()

  • Length: 14.0 Millimeter


  • Craniofacial bone screw, non-bioabsorbable
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
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
Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets. This is a 1.1 gm push syringe of Rely A Bond Paste.
RELIANCE ORTHODONTIC PRODUCTS INC
1.1GRPP
In Commercial Distribution

  • D79811GRPP0 ()
1.1GRPP

  • Orthodontic bracket adhesive
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
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