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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Lower Assy, 3T IOH V2, 110840-000
IMRIS Imaging, Inc.
HC300 Lower Coil
In Commercial Distribution

  • 00857534006226 ()


  • MRI system coil, radio-frequency
SA3 CIC, V2 BE SAPHIRA 3
Bernafon AG
170587
In Commercial Distribution

  • 05711584063040 ()


  • Air-conduction hearing aid, canal
SA5 CIC, V2 BE SAPHIRA 5
Bernafon AG
170586
In Commercial Distribution

  • 05711584063033 ()


  • Air-conduction hearing aid, canal
JU7 CIC, V2 BE JUNA 7
Bernafon AG
170585
In Commercial Distribution

  • 05711584063026 ()


  • Air-conduction hearing aid, canal
JU9 CIC, V2 BE JUNA 9
Bernafon AG
170584
In Commercial Distribution

  • 05711584063019 ()


  • Air-conduction hearing aid, canal
SA5 IIC, V2 BL SAPHIRA 5
Bernafon AG
170071
In Commercial Distribution

  • 05711584062999 ()


  • Air-conduction hearing aid, canal
JU9 IIC, V2 BL JUNA 9
Bernafon AG
170069
In Commercial Distribution

  • 05711584062982 ()


  • Air-conduction hearing aid, canal
GeneChip™ Fluidics Station FS450Dx v2
Affymetrix, Inc.
00-0335
In Commercial Distribution

  • 00856826006029 ()
00-0335

  • Microarray analyser IVD
CR40 CIC, V2 BE CHEER 40
Sonic Innovations, Inc.
170591
In Commercial Distribution

  • 05711583028378 ()


  • Air-conduction hearing aid, canal
CR60 CIC, V2 BE CHEER 60
Sonic Innovations, Inc.
170590
In Commercial Distribution

  • 05711583028361 ()


  • Air-conduction hearing aid, canal
CL80 CIC, V2 BE CELEBRATE 80
Bernafon AG
170589
In Commercial Distribution

  • 05711583028354 ()


  • Air-conduction hearing aid, canal
CL100 CIC, V2 BE CELEBRATE 100
Bernafon AG
170588
In Commercial Distribution

  • 05711583028347 ()


  • Air-conduction hearing aid, canal
CR60 IIC, V2 BL CHEER 60
Sonic Innovations, Inc.
170081
In Commercial Distribution

  • 05711583028330 ()


  • Air-conduction hearing aid, canal
CL100 IIC, V2 BL CELEBRATE 100
Bernafon AG
170078
In Commercial Distribution

  • 05711583028323 ()


  • Air-conduction hearing aid, canal
Upper Assy, 3T IOH V2, 110833-000
IMRIS Imaging, Inc.
HC300 Upper Assy
In Commercial Distribution

  • 00857534006233 ()


  • MRI system coil, radio-frequency
FlexStep V2, 700, 6 step, outdoor
Liftup A/S
FlexStep V2
In Commercial Distribution

  • 05714420070646 ()
107064

  • Assistive passenger lift
FlexStep V2, 700, 5 step, outdoor
Liftup A/S
FlexStep V2
In Commercial Distribution

  • 05714420070639 ()
107063

  • Assistive passenger lift
FlexStep V2, 800, 5 step, outdoor
Liftup A/S
FlexStep V2
In Commercial Distribution

  • 05714420070622 ()
107062

  • Assistive passenger lift
FlexStep V2, 700, 4 step, outdoor
Liftup A/S
FlexStep V2
In Commercial Distribution

  • 05714420070486 ()
107048

  • Assistive passenger lift
FlexStep V2, 800, 6 step, outdoor
Liftup A/S
FlexStep V2
In Commercial Distribution

  • 05714420047785 ()
104778

  • Assistive passenger lift
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