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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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NDDR (National Donor Deferral Registry) - 00812747010217

NDDR version 2.x.x
HAEMONETICS CORPORATION
2.x.x
In Commercial Distribution

  • 00812747010217 ()


  • Clinical laboratory information system application software

Donor Doc - 00812747010200

Donor Doc version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010200 ()


  • Configurable electronic form web-based application software

Symphony - 00812747010194

Symphony version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010194 ()


  • Blood bank information system application software

NexLynk DMS - 00812747010187

NexLynk DMS version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010187 ()


  • Blood bank information system application software

Surround - 00812747010170

Surround version 5.x.x
HAEMONETICS CORPORATION
5.x.x
In Commercial Distribution

  • 00812747010170 ()


  • Blood bank information system application software

McKesson Blood Bank - 00812747010118

McKesson Blood Bank version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010118 ()


  • Blood bank information system application software

SafeTrace Tx - 00812747010101

SafeTrace Tx version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010101 ()


  • Blood bank information system application software

CDCS (Cross Donation Check System) - 00812747010064

CDCS version 1.x.x
HAEMONETICS CORPORATION
1.x.x
In Commercial Distribution

  • 00812747010064 ()


  • Clinical laboratory information system application software

SafeTrace Tx - 00812747010033

SafeTrace Tx version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010033 ()


  • Blood bank information system application software

BloodSafe - 00812747010019

BloodSafe version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010019 ()


  • Clinical laboratory information system application software

BloodTrack - 00812747010002

BloodTrack version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010002 ()


  • Clinical laboratory information system application software

Instrument Manager - B180IMB029000

Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
DATA INNOVATIONS LLC
900
In Commercial Distribution

  • B180IMB029000 ()
IMB02900

  • Clinical laboratory information system application software

Instrument Manager - B180IMB028170

Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
DATA INNOVATIONS LLC
817
In Commercial Distribution

  • B180IMB028170 ()
IMB02817

  • Clinical laboratory information system application software

Instrument Manager - B180IMB028160

Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
DATA INNOVATIONS LLC
816
In Commercial Distribution

  • B180IMB028160 ()
IMB02816

  • Clinical laboratory information system application software

Instrument Manager - B180IMB028150

Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
DATA INNOVATIONS LLC
8150011
Not in Commercial Distribution

  • B180IMB028150 ()
IMB02815

  • Clinical laboratory information system application software

Instrument Manager - B180IMB028140

Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
DATA INNOVATIONS LLC
8141101
Not in Commercial Distribution

  • B180IMB028140 ()
IMB02814

  • Clinical laboratory information system application software

CathCheck Disposable Kit (Pre-assembled) - 00618874601034

CathCheck Disposable Kit (Pre-assembled) to be used with CompuFlo Epidural Computer Controlled Anesthesia System
Milestone Scientific Inc.
EPI-6010-03
In Commercial Distribution

  • 00618874601034 ()


  • Epidural anaesthesia set, non-medicated

DR-ID 1200MC - 04547410289015

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 1200 MC UNIT E
In Commercial Distribution

  • 04547410289015 ()


  • Diagnostic x-ray digital imaging conversion system

DR-ID 1200MC - 04547410288995

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 1200 MC SOFT E
In Commercial Distribution

  • 04547410288995 ()


  • Diagnostic x-ray digital imaging conversion system

DR-ID 600MC - 04547410235937

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 601 MC-WITHOUT SOFT E
In Commercial Distribution

  • 04547410235937 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 900MC - 04547410556452

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 900 MC W MDR E
In Commercial Distribution

  • 04547410556452 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 900MC - 04547410556438

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 900 MC MDR E
In Commercial Distribution

  • 04547410556438 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 900MC - 04547410307061

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 900 MC W E
In Commercial Distribution

  • 04547410307061 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 900MC - 04547410306651

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 900 MC E
In Commercial Distribution

  • 04547410306651 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 670MC - 04547410261189

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 670 MC-WITHOUT SOFT E
In Commercial Distribution

  • 04547410261189 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 600MC - 04547410134551

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 600 MC E
In Commercial Distribution

  • 04547410134551 ()


  • Stationary basic diagnostic x-ray system, digital

BRAEBON USB Cable for MediByte - B14189000

USB Cable for connecting the MediByte to the computer for configuration and data download.
Braebon Medical Corporation
8900
In Commercial Distribution

  • B14189000 ()
8900

  • Electrical-only medical device connection cable, reusable

7D Surgical System - 00628341520379

No Description
7D Surgical ULC
10-0001
In Commercial Distribution

  • 00628341520379 ()


  • Optical surgical navigation device tracking system workstation, mobile

ENVISION 3D: LIGHT HANDLE - 00627843746669

No Description
7D Surgical ULC
11-0005
In Commercial Distribution

  • 00627843746669 ()


  • Optical surgical navigation device tracking system workstation, mobile

ENVISION 3D: IMAGE GUIDANCE SYSTEM - 00627843746614

No Description
7D Surgical ULC
10-0001
In Commercial Distribution

  • 00627843746614 ()


  • Optical surgical navigation device tracking system workstation, mobile

System 4 Quick Set - 00718175004203

System 4 Quick Set
BIODEX MEDICAL SYSTEMS, INC.
840-000
In Commercial Distribution

  • 00718175004203 ()
840-000

  • Biomechanical function analysis system, force-testing, stationary

MJS System 3 Upgrade - 00718175004067

Biodex Multi-Joint-System 3 Rev.1 UpGrade
BIODEX MEDICAL SYSTEMS, INC.
850-822
Not in Commercial Distribution

  • 00718175004067 ()
850-822

  • Biomechanical function analysis system, force-testing, stationary

System 4 MVP - 00718175004401

System 4 MVP
BIODEX MEDICAL SYSTEMS, INC.
852-000
In Commercial Distribution

  • 00718175004401 ()
852-000

  • Biomechanical function analysis system, force-testing, stationary

System 4 Pro - 00718175004005

Biodex System 4 Pro
BIODEX MEDICAL SYSTEMS, INC.
850-000
In Commercial Distribution

  • 00718175004005 ()
850-000

  • Biomechanical function analysis system, force-testing, stationary

n.a. - 04048551325971

Navigation-Panel
Karl Storz GmbH & Co. KG
40800021
In Commercial Distribution

  • 04048551325971 ()


  • Optical surgical navigation device tracking system workstation, mobile

Op.n Core - 03701311501435

No Description
ECENTIAL ROBOTICS
I01014
In Commercial Distribution

  • 03701311501435 ()


  • Optical surgical navigation device tracking system workstation, mobile

Prism - 10850390007380

A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.
BTE TECHNOLOGIES, INC.
Prism1
In Commercial Distribution

  • 10850390007380 ()


  • Biomechanical function analysis system, force-testing, stationary

Provider Test Kit (PTK) - 10850390007359

A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.
BTE TECHNOLOGIES, INC.
1
In Commercial Distribution

  • 10850390007359 ()


  • Biomechanical function analysis system, force-testing, stationary

EvalTech - 10850390007328

A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.
BTE TECHNOLOGIES, INC.
EvalTech
In Commercial Distribution

  • 10850390007328 ()


  • Biomechanical function analysis system, force-testing, stationary

ER - 10850390007311

No Description
BTE TECHNOLOGIES, INC.
ER
Not in Commercial Distribution

  • 10850390007311 ()


  • Biomechanical function analysis system, force-testing, stationary

PrimusRS - 10850390007243

A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
PrimusRS
In Commercial Distribution

  • 10850390007243 ()


  • Biomechanical function analysis system, force-testing, stationary

Primus - 10850390007236

A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
Primus+
Not in Commercial Distribution

  • 10850390007236 ()


  • Biomechanical function analysis system, force-testing, stationary

Simulator II - 10850390007151

A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offers isometric and concentric isotonic modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
Sim II 5
In Commercial Distribution

  • 10850390007151 ()


  • Biomechanical function analysis system, force-testing, stationary

Simulator II - 10850390007137

A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offers isometric and concentric isotonic modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
Sim II 03
In Commercial Distribution

  • 10850390007137 ()


  • Biomechanical function analysis system, force-testing, stationary

REAL INTELLIGENCE - 00885556774151

REAL INTELLIGENCE ROBOTICS CART BASE 220
Smith & Nephew, Inc.
ROB100022
In Commercial Distribution

  • 00885556774151 ()
ROB100022

  • Optical surgical navigation device tracking system workstation, mobile

REAL INTELLIGENCE - 00885556774144

REAL INTELLIGENCE ROBOTICS CART BASE 120
Smith & Nephew, Inc.
ROB100021
In Commercial Distribution

  • 00885556774144 ()
ROB100021

  • Optical surgical navigation device tracking system workstation, mobile

REAL INTELLIGENCE - 00885556756249

REAL INTELLIGENCE ROBOTICS CART COLUMN
Smith & Nephew, Inc.
ROB10002
In Commercial Distribution

  • 00885556756249 ()
ROB10002

  • Optical surgical navigation device tracking system workstation, mobile

Accuray Precision® Treatment Planning System - M65810642700

Software, Version 2.0, Accuray Precision Treatment Planning System The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1064270
In Commercial Distribution

  • M65810642700 ()
NA

  • Radiation therapy treatment planning computer
  • Linear accelerator system

Accuray Precision® Treatment Planning System - M65810617990

Software, Accuray Precision Treatment Planning System, (Version 1.1.1.1) The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1061799
In Commercial Distribution

  • M65810617990 ()
NA

  • Linear accelerator system
  • Radiation therapy treatment planning computer

Accuray Precision® Treatment Planning System - M65810598110

Software, Version 1.1.1, Accuray Precision Treatment Planning System The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1059811
In Commercial Distribution

  • M65810598110 ()
NA

  • Radiation therapy treatment planning computer
  • Linear accelerator system
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