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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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BIOSITE/BIOSITE PLUS - B134JR011AU2

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

BIOSITE/BIOSITE PLUS - B134JR010AU2

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

BIOSITE/BIOSITE PLUS - B134JR009TU2

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

BIOSITE/BIOSITE PLUS - B134JR009HU2

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

BIOSITE/BIOSITE PLUS - B134BI85042

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

BIOSITE/BIOSITE PLUS - B134BI85022

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

BIOSITE/BIOSITE PLUS - B134BI85001

BI8500 60 PSI Transparent Needleless Neutral Valve
MACLIN POWER, INC.
BI8500
In Commercial Distribution

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

  • Intravenous administration tubing extension set

BIOSITE/BIOSITE PLUS - B134BI80042

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

BIOSITE/BIOSITE PLUS - B134BI80022

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

BIOSITE/BIOSITE PLUS - B134BI80001

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 - 06977069493330

Handheld Direct Drive Cable Trainer.
Beyond Power Inc.
HDDT-A1,Beyond Power Voltra I
In Commercial Distribution

  • 06977069493330 ()


  • Body/limb elastic exerciser

buddy, Power Module, 120 - 10896128002500

buddy, Power Module 120V
BELMONT INSTRUMENT CORPORATION
905-00003
Not in Commercial Distribution

  • 10896128002500 ()


  • Conduction blood/fluid warmer

buddy, Power Module, 230V - 10896128002104

buddy, Power Module 230V
BELMONT INSTRUMENT CORPORATION
905-00003A
Not in Commercial Distribution

  • 10896128002104 ()


  • Conduction blood/fluid warmer

Timex TMX - 00715317159715

Power Play Grey Spectacle
Kenmark Optical, Inc.
PWRPGR48
In Commercial Distribution

  • 00715317159715 ()


  • Prescription spectacles

Timex TMX - 00715317159708

Power Play Grey Spectacle
Kenmark Optical, Inc.
PWRPGR46
In Commercial Distribution

  • 00715317159708 ()


  • Prescription spectacles

Timex TMX - 00715317159692

Power Play Blue Spectacle
Kenmark Optical, Inc.
PWRPBL48
In Commercial Distribution

  • 00715317159692 ()


  • Prescription spectacles

Timex TMX - 00715317159685

Power Play Blue Spectacle
Kenmark Optical, Inc.
PWRPBL46
In Commercial Distribution

  • 00715317159685 ()


  • Prescription spectacles

Timex TMX - 00715317159678

Power Play Black Spectacle
Kenmark Optical, Inc.
PWRPBK48
In Commercial Distribution

  • 00715317159678 ()


  • Prescription spectacles

Timex TMX - 00715317159661

Power Play Black Spectacle
Kenmark Optical, Inc.
PWRPBK46
In Commercial Distribution

  • 00715317159661 ()


  • Prescription spectacles

CARDINAL HEALTH - 10195594040970

POWER GLIDE INSERTION KIT
Cardinal Health 200, LLC
17-1742G
In Commercial Distribution

  • 50195594040978 ()
  • 10195594040970 ()
17-1742G

  • General surgical procedure kit, medicated

Relaxis - 00852335007083

Replacement Power Supply, Relaxis
Relaxis
09-0023-01
Not in Commercial Distribution

  • 00852335007083 ()


  • Basic power supply, reusable

DabirAir Accessories - 00851343006330

15' Power Cord Accessory
DABIR SURFACES, INC.
GA-90B2-15
In Commercial Distribution

  • 00851343006330 ()

  • Length: 15 Feet


  • Basic power supply, reusable

DabirAir Accessories - 00851343006026

10' Power Cord Accessory
DABIR SURFACES, INC.
CA-9002-10
In Commercial Distribution

  • 00851343006026 ()

  • Length: 10 Feet


  • Basic power supply, reusable

Power Dental USA - D9437811

POWER WATER RISING SYSTEM
Power Dental U.S.A. Inc.
7811
In Commercial Distribution

  • D9437811 ()
7811

  • Dressing/utility forceps, scissors-like, reusable
  • Intraoperative orthopaedic bone pin/screw, single-use

Power Dental USA - D9437808

POWER BONE SPREADING KIT
Power Dental U.S.A. Inc.
7808
In Commercial Distribution

  • D9437808 ()
7808

  • Dressing/utility forceps, scissors-like, reusable
  • Intraoperative orthopaedic bone pin/screw, single-use

Power Dental USA - D94378030

POWER LATERAL APPROACH KIT
Power Dental U.S.A. Inc.
7803
In Commercial Distribution

  • D94378030 ()
7803

  • Dressing/utility forceps, scissors-like, reusable

Power Dental USA - D94378020

POWER CRESTAL APPROACH KIT
Power Dental U.S.A. Inc.
7802
In Commercial Distribution

  • D94378020 ()
7802

  • Dressing/utility forceps, scissors-like, reusable

Power Dental USA - D9433796

POWER FLEX SPADE KIT
Power Dental U.S.A. Inc.
3796
In Commercial Distribution

  • D9433796 ()
3796

  • Dental elevator, tooth/root

Power Knee - 05690967642839

Power Knee - Trial unit
OSSUR AMERICAS, INC.
PKA01001T
In Commercial Distribution

  • 05690967642839 ()
PKA01001T

  • Motorized external knee prosthesis

Power Knee - 05690967603410

POWER KNEE BATTERY LOANER
OSSUR AMERICAS, INC.
PK23100
Not in Commercial Distribution

  • 05690967603410 ()
PK23100

  • Motorized external knee prosthesis

Power Knee - 05690967556822

POWER KNEE BATTERY UNIT
OSSUR AMERICAS, INC.
PK230010
Not in Commercial Distribution

  • 05690967556822 ()
PK230010

  • Motorized external knee prosthesis

Power Knee - 05690967538804

POWER KNEE II LOANER
OSSUR AMERICAS, INC.
PKN12100
Not in Commercial Distribution

  • 05690967538804 ()
PKN12100

  • Motorized external knee prosthesis

HeartMate™ - 05415067038609

Power Module Backup Battery
Thoratec Corporation
109200
In Commercial Distribution

  • 05415067038609 ()
109200

  • Secondary battery

CardioMEMS™ - 05415067034915

Hospital System Power Cord
CARDIOMEMS, INC.
CM3120
In Commercial Distribution

  • 05415067034915 ()
CM3120

  • Implantable pulmonary artery pressure monitoring system

Power Dental U.S.A., Inc. - D943N78189

POWER BONE TAC CASE
Power Dental U.S.A. Inc.
N7818-9
Not in Commercial Distribution

  • D943N78189 ()
N7818-9

  • Intraoperative orthopaedic bone pin/screw, single-use

Power Dental USA - D943N3796

POWER FLEX SPADE KIT
Power Dental U.S.A. Inc.
N3796
In Commercial Distribution

  • D943N3796 ()
N3796

  • Dental elevator, tooth/root

N/A - 00673978041001

INSTRUMENT 808-555 POWER GRIP
MEDTRONIC SOFAMOR DANEK, INC.
808-555
In Commercial Distribution

  • 00673978041001 ()


  • Surgical vice grip

AcQMap - 00857042007333

Power Cord, Console 2.0
ACUTUS MEDICAL, INC.
800601
Not in Commercial Distribution

  • 00857042007333 ()
800601

  • Electrical-only medical device connection cable, reusable

AcQMap - 00857042007005

North America Power Cord
ACUTUS MEDICAL, INC.
800426
Not in Commercial Distribution

  • 00857042007005 ()
800426

  • Cardiac mapping system

Tenex Health TX® - 00857156006352

Power Cord, 220V, Europe
TENEX HEALTH, INC.
430-4024-001
In Commercial Distribution

  • 00857156006352 ()
430-4024-001

  • Ultrasonic suction system

Tenex Health TX® - 00857156006277

Power Cord, 120V, USA
TENEX HEALTH, INC.
430-4023-001
In Commercial Distribution

  • 00857156006277 ()
430-4023-001

  • Ultrasonic suction system

Sonic - 05711583026886

SPEAKER UNIT, 3R POWER
Sonic Innovations, Inc.
119294
In Commercial Distribution

  • 05711583026886 ()


  • Air-conduction hearing aid, receiver-in-the-ear

Sonic - 05711583026879

SPEAKER UNIT, 3L POWER
Sonic Innovations, Inc.
119293
In Commercial Distribution

  • 05711583026879 ()


  • Air-conduction hearing aid, receiver-in-the-ear

Sonic - 05711583026862

SPEAKER UNIT, 2R POWER
Sonic Innovations, Inc.
119292
In Commercial Distribution

  • 05711583026862 ()


  • Air-conduction hearing aid, receiver-in-the-ear

Sonic - 05711583026855

SPEAKER UNIT, 2L POWER
Sonic Innovations, Inc.
119291
In Commercial Distribution

  • 05711583026855 ()


  • Air-conduction hearing aid, receiver-in-the-ear

Sonic - 05711583026848

SPEAKER UNIT, 1R POWER
Sonic Innovations, Inc.
119290
In Commercial Distribution

  • 05711583026848 ()


  • Air-conduction hearing aid, receiver-in-the-ear

Sonic - 05711583026831

SPEAKER UNIT, 1L POWER
Sonic Innovations, Inc.
119289
In Commercial Distribution

  • 05711583026831 ()


  • Air-conduction hearing aid, receiver-in-the-ear

Sonic - 05711583026824

SPEAKER UNIT, 0R POWER
Sonic Innovations, Inc.
119288
In Commercial Distribution

  • 05711583026824 ()


  • Air-conduction hearing aid, receiver-in-the-ear

Sonic - 05711583026817

SPEAKER UNIT, 0L POWER
Sonic Innovations, Inc.
119287
In Commercial Distribution

  • 05711583026817 ()


  • Air-conduction hearing aid, receiver-in-the-ear

Venclose System Power Cord - 00858254006107

Power Cord, Italy, Chile
VENCLOSE INC
VCPCL
In Commercial Distribution

  • 00858254006107 ()


  • Electrical mains power cable
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