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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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TY-MA - 04260223143700

Tympanometry add-on
PATH medical GmbH
100947-N
In Commercial Distribution

  • 04260223143700 ()


  • Evoked-potential audiometer

Sentiero Advanced - 04260223143632

Sentiero Advanced ABR Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 100468 5. Sentiero Advanced device with touchscreen AN100360 6. ABR electrode cable AN100307 7. Ear coupler cable PECC-HP AN100970 8. Ear coupler (5 pcs.) AN100890-5 9. ABR Quick SW AN100337-Quick 10. Binaural ABR SW AN100424 11. Mira PC Patient Management SW AN100116 12. Label Printer SW AN100414 13. Power Supply Sentiero Advanced US AN101016+AN100993-USA
PATH medical GmbH
100340-SC
In Commercial Distribution

  • 04260223143632 ()


  • Evoked-potential audiometer

Sentiero Advanced - 04260223143625

Sentiero Advanced ABR US0 Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 100468 5. Sentiero Advanced device with touchscreen AN100360 6. ABR electrode cable AN100307 7. PATH Insert Earphones (PIEP) AN100860 8. ABR Quick SW AN100337-Quick 8. Binaural ABR SW AN100424 9. Label Printer SW AN100414 10. Power Supply Sentiero Advanced AN101016 + AN100993-USA
PATH medical GmbH
100340-US0
In Commercial Distribution

  • 04260223143625 ()


  • Evoked-potential audiometer

TY-MA Set - 04260223143618

Set consisting of: (TY-MA, ear tips, probe tips, cavity)
PATH medical GmbH
100947-SET
In Commercial Distribution

  • 04260223143618 ()


  • Evoked-potential audiometer

TY-MA - 04260223143601

Tympanometry add-on
PATH medical GmbH
100947
In Commercial Distribution

  • 04260223143601 ()


  • Evoked-potential audiometer

Ear Coupler Cable - 04260223143595

Ear Coupler Cable (PECC-HP)
PATH medical GmbH
100970
In Commercial Distribution

  • 04260223143595 ()


  • Evoked-potential audiometer

Insert Earphone PIEP monaural - 04260223143564

Bio-Logic branded PIEP monaural (IP-05)
PATH medical GmbH
100867-BL
In Commercial Distribution

  • 04260223143564 ()


  • Evoked-potential audiometer

Sentiero Desktop AuDX PRO FLEX - 04260223143540

Sentiero Desktop AuDX PRO FLEX Set: Content: 1. Sentiero Desktop AN100434-AUPF 2. Cardboard Box AN100728 3. Cardboard Sleeve Bio-Logic AN100723-Biologic 4. Probe EP-TY long AN100188-US 5. Accessory box Combo AB-03 AN100261-BL 6. Accessory box AB08 AN100734-P 7. FW Screening Tymp class 2 AN100560 8. Software label printer AN100414 9. USB data cable AN100418 10. USB stick Bio-Logic AN100724-BL 11. Test cavity tymp AN100549 12. Power supply Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 13. Power supply adapter Sentiero Desktop US AN100525-USA or AN101251-USA optionally 14. Manual Bio-Logic AN100904-EN-BL
PATH medical GmbH
8-04-16540
In Commercial Distribution

  • 04260223143540 ()
100497-BL-US1

  • Evoked-potential audiometer

Sentiero Advanced NavPRO ONE - 04260223143526

Sentiero NavPRO ONE Set: Content: 1. Sentiero Advance device AN100360-NPO 2. Carrying case AN100928 3. Inlay AN100677 4. Insert Earphone PIEP Bio-Logic AN100860-BL 5. Bone Conductor B81 AN100888 or B71W AN100344 optionally 6. Electrode Trunk Cable AN100881 7. Electrode Lead Cable AN100891-1 8. Electrodes AN100468 9. ABR Software AN100337 10. ABR Binaural Software AN100424 11. ABR FFC Software AN100466 12. ECochG Software AN100464 13. Software label printer AN100414 14. PC Patient Management Software AN100116 15. USB data cable AN100089 16. USB stick Bio-Logic AN100724-BL 17. Power supply Sentiero Advanced US AN100268-US 18. Manual Bio-Logic AN100904-EN-BL
PATH medical GmbH
8-04-16550
In Commercial Distribution

  • 04260223143526 ()
100340-BL-US1

  • Evoked-potential audiometer

Sentiero AuDX PRO - 04260223143489

Sentiero AuDX PRO Set: Content: 1. Sentiero Diagnostic device AN100098-AUP 2. Carrying case AN100928 3. Inlay AN100677 4. Probe EP-DP Path long AN100028-US 5. Accessory box Combo AB-03 AN100261-BL 6. TEOAE Software AN100109 7. DPOAE Software AN100110 8. FMDPOAE Software AN100536 9. DPHiRes Software AN100537 10. Software label printer AN100414 11. PC Patient Management Software AN100116 12. USB data cable AN100089 13. USB stick Bio-Logic AN100724-BL 14. Power supply Sentiero AN101013+AN100993-USA 15. Manual Bio-Logic AN100904-EN-BL
PATH medical GmbH
8-04-16530
In Commercial Distribution

  • 04260223143489 ()
100250-BL-US4

  • Evoked-potential audiometer
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