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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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Welch Allyn, Inc. - 00732094265026

E-Scribe ECG Data Management Workstation - Enterprise system, floating; English system language; 220V power; Software Kit;
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094265026 ()
ESWKST-DAB-BXXXX

  • Patient health record information system application software

Welch Allyn, Inc. - 00732094265019

E-Scribe ECG Data Management Workstation - Enterprise system, floating; Italian system language; 220V power; Software Kit;
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094265019 ()
ESWKST-DEB-BXXXX

  • Patient health record information system application software

aScope BronchoSampler™ SC - 05707480137077

Ambu aScope BronchSampler container. Single-use and sterile. Volume of container: 30 ml Minimum purchase is 10 pcs. = 1 box
Ambu A/S
480300000
Not in Commercial Distribution

  • 05707480137084 ()
  • 05707480137077 ()
  • 05707480137091 ()
480300000

  • General-purpose surgical suction system, vacuum

APO CAL - 05055273204414

This product is intended for in-vitro use in the calibration of Apolipoprotein A-I and Apolipoprotein B assays.
RANDOX LABORATORIES LIMITED
LP3023
In Commercial Distribution

  • 05055273204414 ()
LP3023

  • Multiple apolipoprotein IVD, calibrator

Sontro Self-Fitting OTC Hearing Aids - 00850016231086

GREY/990008-SWH; left (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990008-SWH
In Commercial Distribution

  • 00850016231086 ()


  • Air-conduction hearing aid, receiver-in-canal

Sontro Self-Fitting OTC Hearing Aids - 00850016231079

GREY/990007-SWH; right (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990007-SWH
In Commercial Distribution

  • 00850016231079 ()


  • Air-conduction hearing aid, receiver-in-canal

Sontro Self-Fitting OTC Hearing Aids - 00850016231178

BEIGE/990017-SWH; left (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990017-SWH
In Commercial Distribution

  • 00850016231178 ()


  • Air-conduction hearing aid, receiver-in-canal

Sontro Self-Fitting OTC Hearing Aids - 00850016231161

BEIGE/990016-SWH; right (refurbished) replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990016-SWH
In Commercial Distribution

  • 00850016231161 ()


  • Air-conduction hearing aid, receiver-in-canal

STOCKERT EP/IO Interface Box - 04260166370621

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

Visgeneer - 04712558762342

25x2pcs
VISGENEER, INC.
30G I
In Commercial Distribution

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

  • Blood lancet, single-use
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