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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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JR-012-AU Biosite Volumetric Set - 100 Ml
MACLIN POWER, INC.
JR-012-AU
In Commercial Distribution

  • B134JR012AU2 ()
  • B134JR012AU0 ()
JR-012-AU

  • Intravenous administration tubing extension set
JR-011-AU Biosite Regular Set
MACLIN POWER, INC.
JR-011-AU
In Commercial Distribution

  • B134JR011AU2 ()
  • B134JR011AU0 ()
JR-011-AU

  • Intravenous administration tubing extension set
JR-010-AU Biosite Surgical Set
MACLIN POWER, INC.
JR-010-AU
In Commercial Distribution

  • B134JR010AU2 ()
  • B134JR010AU0 ()
JR-010-AU

  • Intravenous administration tubing extension set
JR-009-TU 60 PSI Transparent Needleless Neutral Valve
MACLIN POWER, INC.
JR-009-TU
In Commercial Distribution

  • B134JR009TU2 ()
  • B134JR009TU0 ()
JR-009-TU

  • Intravenous administration tubing extension set
JR-009-HU 300 PSI High-Pressure Needleless Neutral Valve
MACLIN POWER, INC.
JR-009-HU
In Commercial Distribution

  • B134JR009HU2 ()
  • B134JR009HU0 ()
JR-009-HU

  • Intravenous administration tubing extension set
BI8504 Opaque Biosite Plus Neutral Pressure Needleless Valve w/14" Microbore Extension
MACLIN POWER, INC.
BI8504
In Commercial Distribution

  • B134BI85042 ()
  • B134BI85040 ()
BI8504

  • Intravenous administration tubing extension set
BI8502 Opaque Biosite Plus Neutral Pressure Needleless Valve w/8" Microbore Extension
MACLIN POWER, INC.
BI8502
In Commercial Distribution

  • B134BI85022 ()
  • B134BI85020 ()
BI8502

  • Intravenous administration tubing extension set
BI8500 60 PSI Transparent Needleless Neutral Valve
MACLIN POWER, INC.
BI8500
In Commercial Distribution

  • B134BI85001 ()
  • B134BI85000 ()
  • B134BI85002 ()
BI8500

  • Intravenous administration tubing extension set
BI8004 Clear Biosite Plus Neutral Pressure Needleless Valve w/14" Microbore Extension
MACLIN POWER, INC.
BI8004
In Commercial Distribution

  • B134BI80042 ()
  • B134BI80040 ()
BI8004

  • Intravenous administration tubing extension set
BI8002 Clear Biosite Plus Neutral Pressure Needleless Valve w/8" Microbore Extension
MACLIN POWER, INC.
BI8002
In Commercial Distribution

  • B134BI80022 ()
  • B134BI8002 ()
BI8002

  • Intravenous administration tubing extension set
BI8000 Biosite Plus 60psi Transparent Needleless Neutral Valve
MACLIN POWER, INC.
BI8000
In Commercial Distribution

  • B134BI80001 ()
  • B134BI80000 ()
BI8000

  • Intravenous administration tubing extension set
Handheld Direct Drive Cable Trainer.
Beyond Power Inc.
HDDT-A1,Beyond Power Voltra I
In Commercial Distribution

  • 06977069493330 ()


  • Body/limb elastic exerciser
No Description
Zoll Medical Corporation
1110-0013-01
In Commercial Distribution

  • 00847946098964 ()


  • Rechargeable professional automated external defibrillator
PUMP CARTRIDGE, BLOOD, 10 PER CASE (IPN 0040-0051)
Zoll Medical Corporation
1110-0051
In Commercial Distribution

  • 00847946021603 ()


  • Rechargeable professional automated external defibrillator
PUMP CARTRIDGE, CRYSTALLOID/COLLOID, 10 PER CASE (IPN 0040-0050)
Zoll Medical Corporation
1110-0050
In Commercial Distribution

  • 00847946021597 ()


  • Rechargeable professional automated external defibrillator
Power Knee incl 3Y warranty
OSSUR AMERICAS, INC.
PKA10003
In Commercial Distribution

  • 05690967648749 ()
PKA10003

  • Motorized external knee prosthesis
Power Knee incl 2Y warranty
OSSUR AMERICAS, INC.
PKA10001
In Commercial Distribution

  • 05690967648381 ()
PKA10001

  • Motorized external knee prosthesis
POWER KNEE BATT CHARGER LOANER
OSSUR AMERICAS, INC.
PK22100
Not in Commercial Distribution

  • 05690967603427 ()
PK22100

  • Motorized external knee prosthesis
POWERLOGIC II TRAINING SOFTWAR
OSSUR AMERICAS, INC.
PK218001
Not in Commercial Distribution

  • 05690967586669 ()
PK218001

  • Motorized external knee prosthesis
POWERLOGIC II FULL ACCESS
OSSUR AMERICAS, INC.
PK218000
Not in Commercial Distribution

  • 05690967586652 ()
PK218000

  • Motorized external knee prosthesis
POWER KNEE G2 KIT NA TRIAL
OSSUR AMERICAS, INC.
PKN120037
Not in Commercial Distribution

  • 05690967585839 ()
PKN120037

  • Motorized external knee prosthesis
POWER KNEE G2 KIT NA 5 yr warr
OSSUR AMERICAS, INC.
PKN120017
Not in Commercial Distribution

  • 05690967584795 ()
PKN120017

  • Mechatronic external knee prosthesis
POWER KNEE G2 KIT NA EUP
OSSUR AMERICAS, INC.
PKN123007
Not in Commercial Distribution

  • 05690967566029 ()
PKN123007

  • Motorized external knee prosthesis
POWER KNEE BATTERY CHARGER NA
OSSUR AMERICAS, INC.
PK220007
Not in Commercial Distribution

  • 05690967556815 ()
PK220007

  • Motorized external knee prosthesis
POWER KNEE G2 KIT NA
OSSUR AMERICAS, INC.
PKN120007
Not in Commercial Distribution

  • 05690967529772 ()
PKN120007

  • Motorized external knee prosthesis
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0408
In Commercial Distribution

  • 00848665001655 ()


  • Screwing power tool attachment
PPS ANCILLARY PACK, FG PKG
Bayer Healthcare LLC
104834-002
In Commercial Distribution

  • 00616258005102 ()
  • 10616258005109 ()
104834

  • General-purpose catheter connector, sterile
No Description
Biomet Orthopedics, LLC
245014
In Commercial Distribution

  • 00880304288799 ()
245014

  • Orthopaedic implant-instrument extension adaptor, single-use
A device supplying power to the flat panel sensor and connecting between the flat panel sensor and the control cabinet.
FUJIFILM CORPORATION
DR-ID 1200 PB E
In Commercial Distribution

  • 04547410319385 ()


  • Diagnostic x-ray digital imaging conversion system
No Description
Chungwoo Co., Ltd.
SP-30H,IS-14
In Commercial Distribution

  • 08809495931293 ()


  • Electrical mains power cable
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