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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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The Sparrow Ascent Cable is 37 inches long and connects the Patient Controller to the Earpiece. The Cable length is designed to allow the user to carry the Patient Controller in a pocket or worn in the Belt Clip(model 610) without constricting mobility. A built-in retention clip allows the user to clip the Cable to their clothing to relieve cable strain.
Spark Biomedical Inc.
810-P
In Commercial Distribution

  • 00850052017040 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
Grasping Forceps, 5-Pod Type, 2.3mm Diam, 2300mm L
KEY SURGICAL, INC.
EN10137A
Not in Commercial Distribution

  • 00849771041085 ()
  • 00849771039969 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 2300 Millimeter


  • Flexible endoscopic tissue manipulation forceps, single-use
Grasping Forceps, 4-Pod Type, 2.3mm Diam, 2300mm L
KEY SURGICAL, INC.
EN10136A
Not in Commercial Distribution

  • 00849771041078 ()
  • 00849771039952 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 2300 Millimeter


  • Flexible endoscopic tissue manipulation forceps, single-use
Grasping Forceps, 3-Pod Type, 2.3mm Diam, 2300mm L
KEY SURGICAL, INC.
EN10135A
Not in Commercial Distribution

  • 00849771041061 ()
  • 00849771039945 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 2300 Millimeter


  • Flexible endoscopic tissue manipulation forceps, single-use
Retrieval Net, 2.3mm Diam, 2300mm L, 30mm (Net) W, 60mm (Net) H
KEY SURGICAL, INC.
EN10180B
Not in Commercial Distribution

  • 00849771041139 ()
  • 00849771039938 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 2300 Millimeter
  • Width: 30 Millimeter
  • Height: 60 Millimeter


  • Flexible endoscopic tissue manipulation forceps, single-use
Retrieval Net, 2.3mm Diam, 1800mm L, 30mm (Net) W, 60mm (Net) H
KEY SURGICAL, INC.
EN10179B
Not in Commercial Distribution

  • 00849771041122 ()
  • 00849771039914 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 1800 Millimeter
  • Width: 30 Millimeter
  • Height: 60 Millimeter


  • Flexible endoscopic tissue manipulation forceps, single-use
Retrieval Net, 1.8mm Diam, 1600mm L, 30mm (Net) W, 25mm (Net) H
KEY SURGICAL, INC.
EN10178B
Not in Commercial Distribution

  • 00849771041115 ()
  • 00849771039907 ()

  • Outer Diameter: 1.8 Millimeter
  • Length: 1600 Millimeter
  • Width: 15 Millimeter
  • Height: 30 Millimeter


  • Flexible endoscopic tissue manipulation forceps, single-use
Foreign Body Retriever, Alligator Type, 2.3mm Diam, 2300mm L
KEY SURGICAL, INC.
EN10238AB
Not in Commercial Distribution

  • 00849771041030 ()
  • 00849771039891 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 2300 Millimeter


  • Flexible endoscopic tissue manipulation forceps, single-use
Foreign Body Retriever, Rat Type, 2.3mm Diam, 2300mm L
KEY SURGICAL, INC.
EN10237AB
Not in Commercial Distribution

  • 00849771041054 ()
  • 00849771039884 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 2300 Millimeter


  • Flexible endoscopic tissue manipulation forceps, single-use
Foreign Body Retriever, Pelican Type, 2.3mm Diam, 2300mm L
KEY SURGICAL, INC.
EN10235AB
Not in Commercial Distribution

  • 00849771041047 ()
  • 00849771039877 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 2300 Millimeter


  • Flexible endoscopic tissue manipulation forceps, single-use
No Description
PARKS MEDICAL ELECTRONICS, INC.
812-1-F 120V
In Commercial Distribution

  • 00816787020441 ()


  • Laser Doppler blood flowmeter
No Description
PARKS MEDICAL ELECTRONICS, INC.
812-1-F 110V
In Commercial Distribution

  • 00816787020434 ()


  • Laser Doppler blood flowmeter
No Description
PARKS MEDICAL ELECTRONICS, INC.
812 (F) 220V
In Commercial Distribution

  • 00816787020397 ()


  • Laser Doppler blood flowmeter
No Description
PARKS MEDICAL ELECTRONICS, INC.
811-B 24V (F)
In Commercial Distribution

  • 00816787020229 ()


  • Laser Doppler blood flowmeter
The Straight Traction Extension is used to adjust the level of the traction unit assembly and the patients leg relative to the abductor bars.
STERIS CORPORATION
BF268
In Commercial Distribution

  • 00724995158026 ()
BF268

  • Orthopaedic operating table, electrohydraulic
50 curettes-6 pieces of each of the curette styles plus 2 pieces of tweezer attachment
EAR TECHNOLOGY CORPORATION
LB-Variety
In Commercial Distribution

  • 00810323001901 ()


  • Endaural wax extraction curette
  • ENT illuminating foreign body extraction set
  • ENT foreign body extraction forceps
The Tubing is used to transport body fluid from the suction catheter into a collection canister or to transfer vacuum from the pump to the treatment site.
Medela AG
077.0193
In Commercial Distribution

  • 07612367052719 ()
  • 07612367053921 ()


  • Suction/irrigation tubing, single-use
The clamp is used to secure the positioning of the plate onto the bone.
NEWDEAL
189201ND
Not in Commercial Distribution

  • M248189201ND1 ()
  • 10381780051886 ()


  • Implant handling forceps, scissors-like
Accessory to ERT's Asthma Monitor device for professional users
eResearchTechnology GmbH
2.x
In Commercial Distribution

  • 04057155000603 ()


  • Expiratory peak flow meter, digital
DreamMapper iOS APAC Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051355 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051348 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS APAC Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049956 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS APAC Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049109 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049093 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049949 ()
1128264

  • Self-care monitoring/reporting software
for iOS
COCHLEAR LIMITED
6.0
In Commercial Distribution

  • 09321502065764 ()
P1861019

  • Audiometric/hearing device software
for Android
COCHLEAR LIMITED
6.0
In Commercial Distribution

  • 09321502065757 ()
P1860864

  • Audiometric/hearing device software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3536
In Commercial Distribution

  • 00301933536018 ()
85498770

  • Self-care monitoring/reporting software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3537
In Commercial Distribution

  • 00301933537015 ()
85498754

  • Self-care monitoring/reporting software
for iOS
COCHLEAR LIMITED
NSA-1 / v5
In Commercial Distribution

  • 09321502062206 ()
P1834114

  • Audiometric/hearing device software
for Android
COCHLEAR LIMITED
NSA-2 / v5
In Commercial Distribution

  • 09321502062190 ()
P1834165

  • Audiometric/hearing device software
for iOS
COCHLEAR LIMITED
NSA-1 / v4
In Commercial Distribution

  • 09321502060486 ()
P1787372

  • Audiometric/hearing device software
for Android
COCHLEAR LIMITED
NSA-2 / v4
In Commercial Distribution

  • 09321502060479 ()
P1787373

  • Audiometric/hearing device software
Eko mobile app for Android platforms for use with Eko products.
Eko Devices, Inc.
1.2.9
In Commercial Distribution

  • 00863609000341 ()


  • Medical equipment clinical data interfacing software
iOS mobile device software for use with Eko products.
Eko Devices, Inc.
3.1.1
In Commercial Distribution

  • 00863609000334 ()


  • Medical equipment clinical data interfacing software
No Description
NFANT LABS LLC
1
In Commercial Distribution

  • 00861410000246 ()
NA4

  • Biofeedback system application software
The .decimal Astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments.
DECIMAL, INC.
1.0
In Commercial Distribution

  • 00851147007076 ()


  • Radiation therapy software
No Description
Boston Brace International, Inc.
SENSOR-MA-V1
In Commercial Distribution

  • 00860013109813 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
No Description
Thought Technology Ltd.
SA4520
In Commercial Distribution

  • 07540191000623 ()


  • Psychophysiological biofeedback system
Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-02-300
In Commercial Distribution

  • 00817491023537 ()
FG-5502-02-300

  • Implantable glucose monitoring system
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