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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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OPELAIII Cord Clip (Large) - 14589864500213

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500213 ()


  • Head-worn lamp

OPELAIII Cord Clip (Small) - 14589864500206

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500206 ()


  • Head-worn lamp

OPELAIII Antibacterial Urethane Pad - 14589864500176

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
Not in Commercial Distribution

  • 14589864500176 ()


  • Head-worn lamp

OPELAIII Storage Bag (with calibration kit) - 14589864500169

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500169 ()


  • Head-worn lamp

OPELAIII Attached Belt (LL) - 14589864500152

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500152 ()


  • Head-worn lamp

OPELAIII Attached Belt (M-L) - 14589864500145

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500145 ()


  • Head-worn lamp

OPELAIII Dedicated AC Adapter - 14589864500138

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500138 ()


  • Head-worn lamp

OPELAIII Battery Unit - 14589864500121

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500121 ()


  • Head-worn lamp

OPELAIII Main Unit - 14589864500114

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500114 ()


  • Head-worn lamp

OPELAIII Standard Package - 14589864500107

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500107 ()


  • Head-worn lamp

Dr.MUSIC - 00193026000007

No Description
SMART MEDICAL DEVICE Co., Ltd.
DM-VME03s
Not in Commercial Distribution

  • 00193026000007 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

G5 - 00746980000356

The G5 Flimm-Fighter Percussor is the optimum percussor for effective postural drainage at home. The Flimm-Fighter incorporates Directional-Stroking action that helps loosen congestive materials and then moves them into the upper airways, thus promoting airway clearance. The red arrow on the head of the Flimm-Fighter shows the user the direction that the loosened materials are moving inside the body. The ultra-light applicator head, weighing less than one pound, allows a patient to effortlessly receive or self-administer therapy, as it is designed for use with our self application pillow*. The continuously-variable speed range of 20 - 30 cycles per second ensures that patients receive safe, thorough treatment. Comes with applicators 250, 251, 253 & 234. A pediatric version is also available. Unit Advantages: Ideal for COPD, Cystic Fibrosis, Bronchiectasis, Chronic Bronchitis, Atelectasis, Asthma, and Bronchopulmonary Dysplasia patients needing postural drainage Extremely lightweight, the Flimm-Fighter handle weighs less than 1 pound Speed: 20 - 30 cycles per second Can be used with our self application kit* and the Vari-Tilt body positioner *Self Application Kit available separately.
GENERAL PHYSIOTHERAPY INC
FF24B
In Commercial Distribution

  • 00746980000356 ()

  • Weight: 12 Pound
FF24B

  • Hand-held electric massager

WHEELCHAIR - 06977027830610

No Description
Zhejiang Nysin Medical Co.,Ltd
XFGW25-203
In Commercial Distribution

  • 06977027830610 ()


  • Electric-motor-driven wheelchair, occupant-controlled

ViperWire Advance FlexTip - 10852528005329

VIPERWIRE, ADVANCE FLEXTIP PERIPHERAL, .014" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-FT18
In Commercial Distribution

  • 30852528005323 ()
  • 10852528005329 ()

  • Length: 335 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.018 inches
7-10026-02

  • Peripheral vascular guidewire, manual

ViperWire Advance FlexTip - 10852528005312

VIPERWIRE, ADVANCE FLEXTIP PERIPHERAL, .018" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-FT14
In Commercial Distribution

  • 30852528005316 ()
  • 10852528005312 ()

  • Length: 335 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.014 inches
7-10026-01

  • Peripheral vascular guidewire, manual

Diamondback Peripheral - 10852528005282

DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125MICRO145
In Commercial Distribution

  • 10852528005282 ()

  • Crown Type, Micro
  • Intro Sheath 4 Fr
  • Max OD 0.052 inches
  • high speed 140 krmp
  • medium speed 90 krpm
  • low speed 60 krpm
  • Guidewirre 0.014 inches
  • shaft lengh 145 cm
  • nose lengh 7 mm
  • Crown diameter 1.25 mm
7-10024

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005268

DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP–200CLASS145
In Commercial Distribution

  • 10852528005268 ()

  • Crown Type, Classic
  • Intro Sheath 6 Fr
  • Max OD 0.079 inches
  • high speed 140 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • nose length 20 mm
  • Crown Diameter 2.00 mm
7-10017

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005251

DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP–150CLASS145
In Commercial Distribution

  • 10852528005251 ()

  • Crown Type, Classic
  • Intro Sheath 5 Fr
  • Max OD 0.063 inches
  • high speed 140 krpm
  • medium speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire Size OD 0.014 inches
  • shaft length 145 cm
  • Nose Length 15 mm
  • Crown Diameter 1.50 mm
7-10016

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005244

DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125SOLID145
In Commercial Distribution

  • 10852528005244 ()

  • Crown Type, Solid
  • Intro Sheath 4 Fr
  • Max OD 0.052 inches
  • High Speed 120 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire size OD 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 7 mm
  • Crown Diameter 1.25 mm
7-10012

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005237

DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-150SOLID145
In Commercial Distribution

  • 10852528005237 ()

  • Crown Type, Solid
  • Intro Sheath 5 Fr
  • Max OD 0.063 inches
  • High Speed 120 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire Size OD 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 10 mm
  • Crown Diameter 1.50 mm
7-10011

  • Mechanical atherectomy system catheter, peripheral

ViperWire - 10852528005220

VIPERWIRE, ADVANCED, .012" DIA .012" SPRING TIP, 200CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-200
In Commercial Distribution

  • 30852528005224 ()
  • 10852528005220 ()

  • Length: 200 Centimeter
  • Max Shaft Diameter 0.012 inches
  • Max Tip Diameter 0.014 inches
7-10004

  • Peripheral vascular guidewire, manual

Diamondback Peripheral - 10852528005213

DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 60CM SHAFT
Cardiovascular Systems, Inc.
DBP-125SOLID60
In Commercial Distribution

  • 10852528005213 ()

  • Intro Sheath 4 Fr
  • Max OD 0.053 inches
  • High Speed 140 krpm
  • Medium Speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.012 inches
  • Shaft Length 60 cm
  • Nose Length 10 mm
  • Crown Diameter 1.25 mm
  • Crown Type, Solid
7-10002

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005206

DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 60CM SHAFT
Cardiovascular Systems, Inc.
DBP-125MICRO60
In Commercial Distribution

  • 10852528005206 ()

  • Intro Sheath 4 Fr
  • Max OD 0.053 inches
  • High Speed 140 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • guidewire size OD 0.012 inches
  • Shaft Length 60 cm
  • Nose Length 7 mm
  • Crown Size 1.25 mm
  • Crown Type, Micro
7-10001

  • Mechanical atherectomy system catheter, peripheral

COM module for use with the MAC 5500 ST electrocardiograph - 04059358001470

No Description
ergoline GmbH
705780
In Commercial Distribution

  • 04059358001470 ()


  • Bicycle ergometer

VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container, com - 07640172552438

VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container, complete
icotec AG
42-700
In Commercial Distribution

  • 07640172552438 ()
42-700

  • Device sterilization/disinfection container, reusable

FRYE - 00193033618301

No Description
FGX INTERNATIONAL INC.
10266424.COM
In Commercial Distribution

  • 00193033618301 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618295

No Description
FGX INTERNATIONAL INC.
10266423.COM
In Commercial Distribution

  • 00193033618295 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618288

No Description
FGX INTERNATIONAL INC.
10266422.COM
In Commercial Distribution

  • 00193033618288 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618271

No Description
FGX INTERNATIONAL INC.
10266421.COM
In Commercial Distribution

  • 00193033618271 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618264

No Description
FGX INTERNATIONAL INC.
10266420.COM
In Commercial Distribution

  • 00193033618264 ()


  • Tinted non-prescription spectacles
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