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-6065T56
In Commercial Distribution

  • 08057432565029 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6100T55
In Commercial Distribution

  • 08057432565012 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6095T55
In Commercial Distribution

  • 08057432565005 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6090T55
In Commercial Distribution

  • 08057432564992 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6085T55
In Commercial Distribution

  • 08057432564985 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6080T55
In Commercial Distribution

  • 08057432564978 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6075T55
In Commercial Distribution

  • 08057432564961 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6070T55
In Commercial Distribution

  • 08057432564954 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6065T55
In Commercial Distribution

  • 08057432564947 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6100T540
In Commercial Distribution

  • 08057432564930 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6095T540
In Commercial Distribution

  • 08057432564923 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6090T540
In Commercial Distribution

  • 08057432564916 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6085T540
In Commercial Distribution

  • 08057432564909 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6080T540
In Commercial Distribution

  • 08057432564893 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6075T540
In Commercial Distribution

  • 08057432564886 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6070T540
In Commercial Distribution

  • 08057432564879 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6065T540
In Commercial Distribution

  • 08057432564862 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-660T540
In Commercial Distribution

  • 08057432564855 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-655T540
In Commercial Distribution

  • 08057432564848 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-650T540
In Commercial Distribution

  • 08057432564831 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-645T540
In Commercial Distribution

  • 08057432564824 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-640T540
In Commercial Distribution

  • 08057432564817 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-635T540
In Commercial Distribution

  • 08057432564800 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-630T540
In Commercial Distribution

  • 08057432564794 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-620T540
In Commercial Distribution

  • 08057432564770 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-4100T58
In Commercial Distribution

  • 08057432564763 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-4095T58
In Commercial Distribution

  • 08057432564756 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-4090T58
In Commercial Distribution

  • 08057432564749 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-4085T58
In Commercial Distribution

  • 08057432564732 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-430T58
In Commercial Distribution

  • 08057432564725 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-460T56
In Commercial Distribution

  • 08057432564718 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-460T55
In Commercial Distribution

  • 08057432564701 ()


  • Trans-facet-screw internal spinal fixation system, sterile
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
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
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
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
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
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
A clinical information and medical device data system for patient engagement and monitoring of treatment outcomes that can be customised by healthcare professionals to match their treatment pathways. The system can be configured to have diagnostic functionality but does not allow or enable direct diagnosis. No decisive information for making a diagnosis can be provided by the system on its own and it cannot provide diagnosis by itself, nor does it perform as a clinician or provide an indicative diagnosis to the lay user.
FUTURE HEALTH WORKS LTD
MD
In Commercial Distribution

  • G333OUG001 ()


  • Configurable electronic form web-based application software
A clinical information system with a digital goniometer. The system can be configured to have diagnostic functionality but does not allow or enable direct diagnosis. No decisive information for making a diagnosis can be provided by the system on its own and it cannot provide diagnosis by itself, nor does it perform as a clinician or provide an indicative diagnosis to the lay user.
FUTURE HEALTH WORKS LTD
MD
In Commercial Distribution

  • G333KQX001 ()


  • Electronic goniometer/kinesiology sensor
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
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
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
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
The Spect Ophthalmic Camera is a product consisting of an Apple iPhone, a mobile application (app), and an optical lens attachment and illumination source. The mobile app is accessible to users via the Apple App Store (Apple Inc.) for use on Spect issued iPhone devices. The Spect Ophthalmic Camera consists of a mechanical adaptor with a telescopic feature that houses a high-quality glass fundoscopic lens, and a white-light LED illumination source.
Spect Inc.
BOM001
In Commercial Distribution

  • 00853501008002 ()


  • Ophthalmic fundus camera
ENHANCED ALGORITHM ECG EVENT RECORDER https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1058652#
BRAEMAR MANUFACTURING, LLC
900-0557-01
In Commercial Distribution

  • B146ER9B0 ()


  • Electrocardiography telemetric monitoring system
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