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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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None - 00886874110041

CAMERA HEAD STERILE ADAPTER
INTUITIVE SURGICAL, INC.
311613
In Commercial Distribution

  • 00886874110041 ()

  • Outer Diameter: 45 Millimeter


  • Patient surgical drape, reusable

None - 10886874111007

BLUE BLADE
INTUITIVE SURGICAL, INC.
400152
In Commercial Distribution

  • 10886874111007 ()
  • 00886874111000 ()

  • Angle: 15 degree


  • Manual scalpel blade, single-use

Senhance - 00815440021634

Bipolar Maryland Dissector
Asensus Surgical, Inc.
X0007309
In Commercial Distribution

  • 00815440021634 ()

  • Outer Diameter: 3 Millimeter
220-11010

  • Robotic electrosurgical instrument, bipolar, reusable

EndoWrist;daVinci Si - 00886874111451

ENDOPASS DELIVERY
INTUITIVE SURGICAL, INC.
420170
Not in Commercial Distribution

  • 00886874111451 ()

  • Outer Diameter: 8 Millimeter


  • Ligation clip cartridge holder

None - 00886874111086

HARMONIC ACE
INTUITIVE SURGICAL, INC.
400272
In Commercial Distribution

  • 00886874111086 ()
  • 10886874111083 ()

  • Outer Diameter: 5 Millimeter


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use

None - 00886874111048

TIP COVER ACCESSORY
INTUITIVE SURGICAL, INC.
400180
In Commercial Distribution

  • 10886874111045 ()
  • 00886874111048 ()
  • 30886874111049 ()

  • Outer Diameter: 8 Millimeter


  • Electrosurgical system monitor/shield

None - 00886874110997

CANNULA SEAL
INTUITIVE SURGICAL, INC.
400077
In Commercial Distribution

  • 10886874110994 ()
  • 00886874110997 ()

  • Lumen/Inner Diameter: 8 Millimeter


  • Laparoscopic access cannula seal, single-use

EndoWrist;daVinci Si - 00886874111475

MARYLAND BIPOLAR FORCEPS
INTUITIVE SURGICAL, INC.
420172
In Commercial Distribution

  • 00886874111475 ()

  • Outer Diameter: 8 Millimeter


  • Robotic electrosurgical instrument, bipolar, reusable

Force Feedback - 00886874125588

Force Feedback Fenestrated Bipolar Forceps
INTUITIVE SURGICAL, INC.
476205
In Commercial Distribution

  • 00886874125588 ()

  • Outer Diameter: 8 Millimeter


  • Robotic electrosurgical instrument, bipolar, reusable

Remote Network Station - 00851725007283

No Audio Remote Network Station with Dell OptiPlex 7490 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7490
In Commercial Distribution

  • 00851725007283 ()
RNS-6804-7490

  • Centralized patient monitor

Remote Network Station - 00851725007221

No Audio Remote Network Station with Dell OptiPlex 7480 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7480
In Commercial Distribution

  • 00851725007221 ()
RNS-6804-7480

  • Centralized patient monitor

Remote Network Station - 00851725007207

No Audio Remote Network Station with Dell OptiPlex 7470 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7470
In Commercial Distribution

  • 00851725007207 ()
RNS-6804-7470

  • Centralized patient monitor

Remote Network Station - 00851725007177

No Audio Remote Network Station with Dell OptiPlex 7460 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7460
In Commercial Distribution

  • 00851725007177 ()
RNS-6804-7460

  • Centralized patient monitor

ATLAS Workstation - 00850011306949

The ATLAS Workstation is a computer that runs the Data Acquisition Software.
NEURALYNX, INC.
ATLAS Workstation
In Commercial Distribution

  • 00850011306949 ()
31-0004-0000

  • Electroencephalographic monitoring system

Epidural Disposable Kit - 00618874601102

Epidural Disposable Kit for use with CompuFlo Epidural Computer Controlled Anesthesia System
Milestone Scientific Inc.
EPI-6011
In Commercial Distribution

  • 00618874601102 ()


  • Electronic epidural space locator pressure-sensing set

QVCAD System - B630QVCS346

Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.6
Not in Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System - B630QVCS344

Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.4
In Commercial Distribution



  • Ultrasound imaging system application software

BRAEBON MediByte - B14088900

Cable to connect MediByte to a computer for configuration and data upload.
Braebon Medical Corporation
8890
In Commercial Distribution

  • B14088900 ()
8890

  • Electrical-only medical device connection cable, reusable

ThinPrep Imaging System - 15420045504042

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045504042 ()
ASY-08388

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045501041

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045501041 ()
ASY-06030

  • Laboratory instrument/analyser application software IVD
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