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=677511#
SAGEMAX BIOCERAMICS, INC
W-22113
Not in Commercial Distribution

  • 00814356021233 ()


  • Dental appliance fabrication material, ceramic
Spacerhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=71318#
UNIFIED SPINE, LLC
502308
In Commercial Distribution

  • M9935023080 ()

  • Height: 8 Millimeter


  • Orthopaedic bone fixation plate spacer
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=680752#
SPES MEDICA SPA
TFDN452501
In Commercial Distribution

  • 18054655015154 ()
  • 08054655015157 ()


  • Electromyographic needle electrode, single-use
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: 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
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
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
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
No Description
STARKEY LABORATORIES, INC.
Thrive Hearing Control for iOS
In Commercial Distribution

  • 00842318130792 ()


  • Audiometric/hearing device software
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
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