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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Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 18", 1 temperature probe, 2 CO2 canisters 2.5lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution

  • 00860003258415 ()


  • Laboratory refrigerator/freezer
Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 13", 1 temperature probe, 2 CO2 canisters 1lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution

  • 00860003258408 ()


  • Laboratory refrigerator/freezer
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
Evok 1600 Wireless
In Commercial Distribution

  • 00851362008070 ()


  • Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
RxEars RX8
In Commercial Distribution

  • 00851362008056 ()


  • Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
RxEars RX7
In Commercial Distribution

  • 00851362008018 ()


  • Air-conduction hearing aid, behind-the-ear
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8050002S
Not in Commercial Distribution

  • ENTTUTG2CON8050002S1 ()

  • 2-CONnect®-Abutment Set Ø 5,0 mm; gingiva height 2,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8050002S

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8050001S
Not in Commercial Distribution

  • ENTTUTG2CON8050001S1 ()

  • 2-CONnect®-Abutment Set Ø 5,0 mm; gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8050001S

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8033422M
Not in Commercial Distribution

  • ENTTUTG2CON8033422M1 ()

  • 2-CONnect®-Abutment Ø 3,3 - 4,25 mm; gingiva height 2,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8033422M

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8033421M
Not in Commercial Distribution

  • ENTTUTG2CON8033421M1 ()

  • 2-CONnect®-Abutment Ø 3,3 - 4,25 mm; gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8033421M

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
VALIDATE THY2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: Thyroglobulin (Tg).
Lgc Clinical Diagnostics, Inc.
908ro
In Commercial Distribution

  • 00850011135600 ()


  • Thyroglobulin IVD, control
ARYS pro is intended to track and organize patient health and activity information recorded by sensors on the paretic and healthy wrist and using a mobile app for visualization.
tyromotion GmbH
3
In Commercial Distribution

  • 09120077180120 ()


  • Biomechanical function analysis/rehabilitation software
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 80500A3M
Not in Commercial Distribution

  • ENTTUTG2CON80500A3M1 ()

  • 2-CONnect®-Abutment Ø 5,0 mm; gingiva height 2,5 mm; angled 20°; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 80500A3M

  • Dental implant suprastructure, permanent, preformed
  • Dental prosthesis/implant abutment screw
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8033422S
Not in Commercial Distribution

  • ENTTUTG2CON8033422S1 ()

  • 2-CONnect®-Abutment Set Ø 3,3 - 4,25 mm; gingiva height 2,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8033422S

  • Dental implant suprastructure, permanent, preformed
  • Dental prosthesis/implant abutment screw
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8033421S
Not in Commercial Distribution

  • ENTTUTG2CON8033421S1 ()

  • 2-CONnect®-Abutment Set Ø 3,3 - 4,25 mm; gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8033421S

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
25x2pcs
VISGENEER, INC.
30G I
In Commercial Distribution

  • 04712558762342 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

  • Blood lancet, single-use
No Description
Stockert GmbH
S7032
Not in Commercial Distribution

  • 04260166370621 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

  • Percutaneous radio-frequency ablation system generator
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-12-9308
In Commercial Distribution

  • 09348215045753 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

  • Non-constrained polyethylene acetabular liner
Extra-Wide, Adjustable Height Armboard (SWISS)
SCHUERCH CORPORATION
800-0017-SWISS
In Commercial Distribution

  • 00810057373046 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

  • Arm procedure positioner, reusable
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 80500A3S
Not in Commercial Distribution

  • ENTTUTG2CON80500A3S1 ()

  • 2-CONnect®-Abutment Set Ø 5,0 mm; gingiva height 2,5 mm; angled 20°; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 80500A3S

  • Dental implant suprastructure, permanent, preformed
  • Dental prosthesis/implant abutment screw
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 80334A3M
Not in Commercial Distribution

  • ENTTUTG2CON80334A3M1 ()

  • 2-CONnect®-Abutment Ø 3,3 - 4,25 mm; gingiva height 2,5 mm; angled 20°;Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 80334A3M

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
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