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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No Description
Natus Medical Denmark ApS
DISC ELECTR,GLD, 9MM,48 IN,RED
In Commercial Distribution

  • 05713315003028 ()


  • Auditory stimulator
No Description
Natus Medical Denmark ApS
DISC ELECTR,GLD, 9MM,48 IN,BLU
In Commercial Distribution

  • 05713315003011 ()


  • Auditory stimulator
No Description
Natus Medical Denmark ApS
DSC ELTRD,GLD,EP,9MM,48IN,PK/8
In Commercial Distribution

  • 05713315003103 ()


  • Auditory stimulator
No Description
Natus Medical Denmark ApS
DISC ELTRD,GLD,EP,9MM,48,PKG/5
In Commercial Distribution

  • 05713315003097 ()


  • Auditory stimulator
Sentiero Desktop Diagnostic Set US7 Diagnostic Tymp with Diagnostic OAE Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 2. USB data cable AN100418 3. Probe EP-TY long AN100188-US 4. Probe EP-DP VIP blue AN100539-US 5. FW Reflex & Tymp class1 AN100561 6. Software label printer AN100414 7. DPOAE Software AN100110 8. TEOAE Software AN100109 9. DPHiRES Software AN100537 10. FMDPOAE Software AN100536 11. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN100116 12. Accessory box for Tymp probe AN100587 13. Accessory box AB08 AN100734-P 14. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 15. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally 16. Test cavity tymp AN100549
PATH medical GmbH
100497-US7
In Commercial Distribution

  • 04260223141539 ()


  • Evoked-potential audiometer
Sentiero Desktop Diagnostic Set US8 Diagnostic Tymp with Diagnostic OAE and DPOAE threshold estimation Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 2. USB data cable AN100418 3. Probe EP-TY long AN100188-US 4. Probe EP-DP VIP blue AN100539-US 5. FW Reflex & Tymp class1 AN100561 6. Software label printer AN100414 7. DPOAE Software AN100110 8. TEOAE Software AN100109 9. DPHiRES Software AN100537 10. FMDPOAE Software AN100536 11. DPOAE Threshold Estimation Software AN100111 12. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN100116 13. Accessory box for Tymp probe AN100587 14. Accessory box AB08 AN100734-P 15. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 16. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally 17. Test cavity tymp AN100549
PATH medical GmbH
100497-US8
In Commercial Distribution

  • 04260223141546 ()


  • Evoked-potential audiometer
Sentiero Desktop Diagnostic Set US9 Diagnostic OAE with Diagnostic Tymp, Audio, DPOAE Threshold estimation software, Simultaneous DPOAE measurements on both ears (two probes incl.) Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 2. USB data cable AN100418 3. Probe EP-TY long AN100188-US 4. Probe EP-DP VIP blue AN100539-US 5. DD45 HB7 headphone (calibrated) AN100306-US 6. Bone conductor B81 (calibrated) AN100888 or B71W optionally. 7. Gooseneck microphone AN100779 8. FW Reflex & Tymp class1 AN100561 9. Software label printer AN100414 10. Label printer cable Senti / Sentiero desktop AN100417 11. DPOAE Software AN100110 12. TEOAE Software AN100109 13. DPHiRES Software AN100537 14. FMDPOAE Software AN100536 15. DPOAE Threshold Estimation Software AN100111 16. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN100116 17. FW Live AN100825 18. UT-08 Spondee Words for Children (English) AN100819 19. UT-10 Spondee Words for Adults (English) AN100821 20. UT-11 Northwestern University Auditory Test No. 6 (English) AN100822 21. UT-12 Central Institute for the Deaf W22 AN100823 22. UT-13 PBK-50 (English) AN100824 23. Accessory box for Tymp probe AN100587 24. Accessory box AB08 AN100734-P 25. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 26. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally 27. Test cavity tymp AN100549 28. PTA Class 3 Software AN100114
PATH medical GmbH
100497-US9
In Commercial Distribution

  • 04260223141553 ()


  • Evoked-potential audiometer
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