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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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VersaCross Steerable Sheath - 00685447005735

1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
Baylis Médicale Cie Inc
VST85-35-BD-71L-D0
In Commercial Distribution

  • 00685447005735 ()

  • 72cm 8.5F VersaCross Steerable Sheath with large curl; 180cm J-Tip Guidewire with OD = 0.035 inch; 8.5F 95cm VersaCross Transseptal Dilator with D0
NA

  • Vascular guide-catheter, single-use

VersaCross Steerable Sheath - 00685447010203

1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
Baylis Médicale Cie Inc
VST0017
In Commercial Distribution

  • 00685447010203 ()

  • 63cm 8.5F VersaCross Steerable Sheath with large curl; 180cm J-Tip Guidewire with OD = 0.035 inch; 8.5F 85cm VersaCross Transseptal Dilator with D1


  • Vascular guide-catheter, single-use

VersaCross Steerable Sheath - 00685447010180

1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
Baylis Médicale Cie Inc
VST0013
In Commercial Distribution

  • 00685447010180 ()

  • 63cm 8.5F VersaCross Steerable Sheath with medium curl; 180cm J-Tip Guidewire with OD = 0.035 inch; 8.5F 85cm VersaCross Transseptal Dilator with D1


  • Vascular guide-catheter, single-use

VersaCross Steerable Sheath - 00685447010173

1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
Baylis Médicale Cie Inc
VST0011
In Commercial Distribution

  • 00685447010173 ()

  • 63cm 8.5F VersaCross Steerable Sheath with medium curl; 180cm J-Tip Guidewire with OD = 0.035 inch; 8.5F 85cm VersaCross Transseptal Dilator with D0


  • Vascular guide-catheter, single-use

VersaCross Steerable Sheath - 00685447010166

1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
Baylis Médicale Cie Inc
VST0009
In Commercial Distribution

  • 00685447010166 ()

  • 63cm 8.5F VersaCross Steerable Sheath with small curl; 180cm J-Tip Guidewire with OD = 0.035 inch; 8.5F 85cm VersaCross Transseptal Dilator with D1


  • Vascular guide-catheter, single-use

Siemens - 05711781000749

Siemens UNITY 3 WITH INSERT
Ws Audiology Usa, Inc.
UNITY 3 WITH INSERT
Not in Commercial Distribution

  • 05711781000749 ()
10824331

  • Audiometric/hearing aid tester

ProSomnus EVO Sleep and Snore Device with Patient Monitoring - 00863039000492

No Description
PROSOMNUS SLEEP TECHNOLOGIES
EVO with Patient Monitoring
In Commercial Distribution

  • 00863039000492 ()


  • Mandible-repositioning sleep-disordered breathing orthosis

GN Otometrics A/S - 05713315005701

No Description
Natus Medical Denmark ApS
REM Tube with ruler
In Commercial Distribution

  • 05713315005701 ()


  • Hearing aid tester, electrical

GN Otometrics A/S - 05713315005527

1081 AURICAL (PMM, C&S) with HI-PRO (US only)
Natus Medical Denmark ApS
1081 AURICAL with HI-PRO
In Commercial Distribution

  • 05713315005527 ()
8-04-14536

  • Speech audiometer
  • Tone audiometer

GN Otometrics A/S - 05713315002373

No Description
Natus Medical Denmark ApS
PROBE TIP WITH TUBES
In Commercial Distribution

  • 05713315002373 ()


  • Impedance audiometer
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