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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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Bioseal Inc. - 00630094043128

Penrose Drain
BIOSEAL
4312/24
In Commercial Distribution

  • 10630094043125 ()
  • 00630094043128 ()


  • Surgical capillary wound drain, luminal, synthetic polymer

Bioseal Inc. - 00630094043111

Penrose Drain
BIOSEAL
4311/24
In Commercial Distribution

  • 10630094043118 ()
  • 00630094043111 ()


  • Surgical capillary wound drain, luminal, synthetic polymer

Bioseal Inc. - 00630094043081

Penrose Drain
BIOSEAL
4308/24
In Commercial Distribution

  • 10630094043088 ()
  • 00630094043081 ()


  • Surgical capillary wound drain, luminal, synthetic polymer

Bioseal Inc. - 00630094042947

Cigarette Drain
BIOSEAL
4299/24
In Commercial Distribution

  • 10630094042999 ()
  • 00630094042947 ()


  • Surgical capillary wound drain, luminal, synthetic polymer

Bioseal Inc. - 00630094042657

Elastic Bandage
BIOSEAL
4265/25
In Commercial Distribution

  • 10630094042654 ()
  • 00630094042657 ()


  • Pressure bandage, non-latex, single-use

Bioseal Inc. - 00630094042251

Elastic Bandage
BIOSEAL
4225/25
In Commercial Distribution

  • 10630094042258 ()
  • 00630094042251 ()


  • Pressure bandage, non-latex, single-use

Bioseal Inc. - 00630094041650

Elastic Bandage Tensor
BIOSEAL
4165/24
In Commercial Distribution

  • 10630094041657 ()
  • 00630094041650 ()


  • Pressure bandage, non-latex, single-use

Bioseal Inc. - 00630094041469

Elastic Bandage
BIOSEAL
4146/10
In Commercial Distribution

  • 10630094041466 ()
  • 00630094041469 ()


  • Pressure bandage, non-latex, single-use

Bioseal Inc. - 00630094041452

Elastic Bandage
BIOSEAL
4145/24
In Commercial Distribution

  • 10630094041459 ()
  • 00630094041452 ()


  • Pressure bandage, non-latex, single-use

Bioseal Inc. - 00630094041438

Catheter Plug
BIOSEAL
0414L/24
In Commercial Distribution

  • 10630094041435 ()
  • 00630094041438 ()


  • Catheter orifice occluder

Bioseal Inc. - 00630094040660

Cohesive Bandage
BIOSEAL
4066/24
In Commercial Distribution

  • 10630094040667 ()
  • 00630094040660 ()


  • Pressure bandage, non-latex, single-use

Bioseal Inc. - 00630094040653

Self Adherent Bandage
BIOSEAL
4065/24
In Commercial Distribution

  • 10630094040650 ()
  • 00630094040653 ()


  • Pressure bandage, non-latex, single-use

Bioseal Inc. - 00630094040479

Coban Bandage
BIOSEAL
4047/24
In Commercial Distribution

  • 10630094040476 ()
  • 00630094040479 ()


  • Pressure bandage, non-latex, single-use

Bioseal Inc. - 00630094040462

Cohesive Bandage
BIOSEAL
4046/24
In Commercial Distribution

  • 10630094040469 ()
  • 00630094040462 ()


  • Pressure bandage, non-latex, single-use

Bioseal Inc. - 00630094040455

Self Adherent Bandage Coban
BIOSEAL
4045/24
In Commercial Distribution

  • 10630094040452 ()
  • 00630094040455 ()


  • Pressure bandage, non-latex, single-use

Bioseal Inc. - 00630094040363

Cohesive Bandage
BIOSEAL
4036/24
In Commercial Distribution

  • 10630094040360 ()
  • 00630094040363 ()


  • Pressure bandage, non-latex, single-use

Bioseal Inc. - 00630094040356

Self Adherent Bandage Coban
BIOSEAL
4035/24
In Commercial Distribution

  • 10630094040353 ()
  • 00630094040356 ()


  • Pressure bandage, non-latex, single-use

Bioseal Inc. - 00630094040264

Cohesive Bandage
BIOSEAL
4026/24
In Commercial Distribution

  • 10630094040261 ()
  • 00630094040264 ()


  • Pressure bandage, non-latex, single-use

Bioseal Inc. - 00630094040257

Self Adherent Bandage Coban
BIOSEAL
4025/24
In Commercial Distribution

  • 10630094040254 ()
  • 00630094040257 ()


  • Pressure bandage, non-latex, single-use

Bioseal Inc. - 00630094040165

Cohesive Bandage
BIOSEAL
4016/24
In Commercial Distribution

  • 10630094040162 ()
  • 00630094040165 ()


  • Pressure bandage, non-latex, single-use

Bioseal Inc. - 00630094040158

Self Adherent Bandage Coban
BIOSEAL
4015/30
In Commercial Distribution

  • 10630094040155 ()
  • 00630094040158 ()


  • Pressure bandage, non-latex, single-use

LARYNGOSTROBOSCOPE - 04961333255726

9500FS, Footswitch "Accessory for 9500 "
PENTAX OF AMERICA, INC.
9500FS
In Commercial Distribution

  • 04961333255726 ()


  • Laryngostroboscope

LARYNGOSTROBOSCOPE - 04961333255719

9500MC, Lapel Microphone "Accessory for 9500"
PENTAX OF AMERICA, INC.
9500MC
In Commercial Distribution

  • 04961333255719 ()


  • Laryngostroboscope

LARYNGOSTROBOSCOPE - 04961333255702

9500LX, Laryngeal Microphone "Accessory for 9500"
PENTAX OF AMERICA, INC.
9500LX
In Commercial Distribution

  • 04961333255702 ()


  • Laryngostroboscope

C2 CryoBalloon - 04961333255320

No Description
PENTAX OF AMERICA, INC.
FG-1056
In Commercial Distribution

  • 04961333255320 ()


  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

C2 CryoBalloon - 04961333255313

No Description
PENTAX OF AMERICA, INC.
FG-1055
In Commercial Distribution

  • 04961333255313 ()


  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

LARYNGOSTROBOSCOPE - 04961333255016

LARYNGEAL STROBE 9500
PENTAX OF AMERICA, INC.
9500
In Commercial Distribution

  • 04961333255016 ()


  • Laryngostroboscope

MULTI-SPEECH - 04961333254309

Multi-Speech Microphone, Condensor
PENTAX OF AMERICA, INC.
3706-1
In Commercial Distribution

  • 04961333254309 ()


  • Voice amplification system

PENTAX - 04961333253951

Balloon/O-Ring Kit OF-A67
HOYA CORPORATION
OF-A67
In Commercial Distribution

  • 84961333253957 ()
  • 04961333253951 ()


  • Ultrasound endoscope balloon, synthetic polymer

PENTAX Medical - 04961333253944

PENTAX Medical Single Use Balloon OE-A61
HOYA CORPORATION
OE-A61
In Commercial Distribution

  • 84961333253940 ()
  • 04961333253944 ()


  • Ultrasound endoscope balloon, synthetic polymer
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