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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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CARDINAL HEALTH - 10197106119266

UNIVERSITY PACEMAKER PACK
Cardinal Health 200, LLC
SAN15UPM26
In Commercial Distribution

  • 50197106119264 ()
  • 10197106119266 ()
SAN15UPM26

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10198956100688

UNIVERSITY PACEMAKER PACK
Cardinal Health 200, LLC
SAN15UPM39
In Commercial Distribution

  • 50198956100686 ()
  • 10198956100688 ()
SAN15UPM39

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10887488564746

KIT, TOTAL KNEE, HILLSDALE COM
Cardinal Health 200, LLC
POW1TKHIM
In Commercial Distribution

  • 50887488564744 ()
  • 10887488564746 ()
POW1TKHIM

  • Orthopaedic surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10193489391145

PK CUST NEURO CABRINI COM
MEDLINE INDUSTRIES, INC.
DYNJ60585A
In Commercial Distribution

  • 40193489391146 ()
  • 10193489391145 ()
DYNJ60585A

  • General surgical procedure kit, non-medicated, single-use

NAMIC - 10193489075182

3,PORT,KIT,COM HOSP
MEDLINE INDUSTRIES, INC.
650311521
In Commercial Distribution

  • 10193489075182 ()
  • 20193489075189 ()
650311521

  • Angiography kit

CARDINAL HEALTH - 10888439513165

KIT,TOTAL KNEE, NORTHWEST COM
Cardinal Health 200, LLC
POCGTKNWM
In Commercial Distribution

  • 50888439513163 ()
  • 10888439513165 ()
POCGTKNWM

  • Orthopaedic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10887488551425

KIT,TOTAL KNEE, NORTHWEST COM
Cardinal Health 200, LLC
POCGTKNWL
In Commercial Distribution

  • 50887488551423 ()
  • 10887488551425 ()
POCGTKNWL

  • Orthopaedic surgical procedure kit, non-medicated, single-use

SpO2.COM® NRC-GE Patient Cable - 00843997001397

SpO2.COM NRC-GE Patient Cable
MASIMO CORPORATION
1854
In Commercial Distribution

  • 00843997001397 ()
1854

  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-395 Patient Cable - 00843997001366

SpO2.COM NRC-395 Patient Cable
MASIMO CORPORATION
1811
In Commercial Distribution

  • 00843997001366 ()
1811

  • Electrical-only medical device connection cable, reusable

Medline Industries, Inc. - 10193489986297

3 PORT KIT COM HOSP
MEDLINE INDUSTRIES, INC.
650311521
In Commercial Distribution

  • 40193489986298 ()
  • 10193489986297 ()
650311521

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10193489523652

PK CUST NEURO CABRINI COM
MEDLINE INDUSTRIES, INC.
DYNJ60585
In Commercial Distribution

  • 10193489523652 ()
DYNJ60585

  • General surgical procedure kit, non-medicated, single-use

Supremo Instrumentos - 07908854000890

Broca Coletora com Capa 7.0
ANDRE GREGATE BRAGA INSTRUMENTOS LTDA
S7923
In Commercial Distribution

  • 07908854000890 ()


  • Surgical screwdriver, reusable

NORDENT MANUFACTURING INC - 00840018636057

SPECIAL COM PLACM PER MICRODEN
NORDENT MANUFACTURING INC
PFICOMP14
In Commercial Distribution

  • 00840018636057 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635746

COM PLACEMENT INST DE WOODSN #
NORDENT MANUFACTURING INC
CEPFIW1
In Commercial Distribution

  • 00840018635746 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635548

COM PLACEMENT INST DE WOODSN #
NORDENT MANUFACTURING INC
REPFIW1
In Commercial Distribution

  • 00840018635548 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635401

COM PLACEM INSTDE, #37, DL-RND
NORDENT MANUFACTURING INC
REPFI37
In Commercial Distribution

  • 00840018635401 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018634961

COM PLACEMENT INST DE - HOE
NORDENT MANUFACTURING INC
PFI4A-MT40
In Commercial Distribution

  • 00840018634961 ()


  • Margin finishing dental file/rasp, reusable

Easy III - 00840067100622

Easy III Power Com Module
CADWELL INDUSTRIES, INC.
190245-200
In Commercial Distribution

  • 00840067100622 ()


  • Electroencephalograph

Cascade Elite - 00840067100295

Cascade Elite Power/Com Module
CADWELL INDUSTRIES, INC.
190240-200
In Commercial Distribution

  • 00840067100295 ()


  • Neurophysiologic monitoring system

Medline Industries, Inc. - 10195327605544

PK CUST NEURO CABRINI COM
MEDLINE INDUSTRIES, INC.
DYNJ60585C
In Commercial Distribution

  • 40195327605545 ()
  • 10195327605544 ()
DYNJ60585C

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327547776

PK CUST NEURO CABRINI COM
MEDLINE INDUSTRIES, INC.
DYNJ60585B
In Commercial Distribution

  • 40195327547777 ()
  • 10195327547776 ()
DYNJ60585B

  • General surgical procedure kit, non-medicated, single-use

Brasseler USA - 00887919801467

K0354 MCLAREN UAB COM/BISACRYL
Peter Brasseler Holdings, LLC
5026493U0
In Commercial Distribution

  • 00887919801467 ()


  • Diamond dental bur, single-use

Vermed Holter Kit - 10813150021255

Packed for Cardio Options, Jacksonville, FL 32223 25 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
CARD98-3
In Commercial Distribution

  • 10813150021255 ()
  • 00813150021258 ()
CARD98-3

  • Electrocardiographic long-term ambulatory recording support kit

Vermed Holter Kit - 10813150021248

Packed for Cardio Options, Jacksonville, FL 32223 25 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
CARD98-2
In Commercial Distribution

  • 10813150021248 ()
  • 00813150021241 ()
CARD98-2

  • Electrocardiographic long-term ambulatory recording support kit

NeXus-Q32 - 08719481550400

The NeXus-Q32 is intended for acquisition of (electro)-physiological signals (e.g. EEG, surface EMG or ECG) from humans, regardless of any specific medical indication, by medical/research professionals.
Mind Media Europe B.V.
3.0
In Commercial Distribution

  • 08719481550400 ()


  • Multiple physiological signal amplifier

NeXus-10 MKII - 08719481550349

The NeXus-10 MKII is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG). The product is intended to be used by medical/acces professionals in a laboratory setup or medical office, or to be set-up in such an environment after which the subject/patient can be sent out while signal acquisition continues on memory. The NeXus 10 MKII is not intended for use in diagnosis, nor in critical and/or life supporting applications. The NeXus 10 MKII is intended for use on humans. The NeXus 10 MKII is intended to be used with approved NeXus 10 MKII accessories only. Specifically, (active) sensors intended to measure specific physiological signals, shall be designed in accordance with the specifications of the NeXus-10 MKII and may require interpretation by user or application software.
Mind Media Europe B.V.
1.2
In Commercial Distribution

  • 08719481550349 ()


  • Multiple physiological signal amplifier

NeXus Software - 08719481550332

The NeXus software is intended to provide (near) real-time biofeedback and neurofeedback in the form of information, visual and auditory signals, corresponding to the state of one or more physiological parameters, so that a patient can learn voluntary control of these parameters. The software shall be used on a personal computer (in a medical office environment) in combination with compatible signal acquisition devices and sensor accessories to perform its intended use. The software is designed for medical use, not restricted to a specific medical indication. It is intended to be used within a medical office environment by, or under supervision of, a health professional (novice user, technical knowledge, normal eyesight, possibly achieved with the aid of glasses). The software is not intended for use in a life support application nor is it intended for diagnostic purposes.
Mind Media Europe B.V.
1.0.204.6
In Commercial Distribution

  • 08719481550332 ()


  • Biofeedback system application software

GSR-TMP Combination Sensor (NC-C-GT) - 08719481550097

NC-C-GT: The GSR sensor provides a measure of skin resistance or skin conductance when connected to a NeXus signal acquisition device, which is influenced by the autonomic activation of sweat glands in the skin. The sensor output is not intended to be used for vital monitoring purposes. The temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connected to a NeXus signal acquisition device. The sensor shall be placed on intact skin to provide a signal that is influenced by cutaneous blood flow. The sensor is not intended to determine directly or indirectly a measure of core body temperature and to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
Mind Media Europe B.V.
1.0
In Commercial Distribution

  • 08719481550097 ()


  • General-purpose patient temperature probe, reusable
  • Skin electrical conductance meter

Temperature Sensor (NB-TMP) - 08719481550080

NB-TMP: The temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connected to a NeXus signal acquisition device. The sensor shall be placed on intact skin to provide a signal that is influenced by cutaneous blood flow. The sensor is not intended to determine directly or indirectly a measure of core body temperature and to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
Mind Media Europe B.V.
1.0
In Commercial Distribution

  • 08719481550080 ()


  • General-purpose patient temperature probe, reusable

Galvanic Skin Response Sensor (NB-GSR) - 08719481550073

NB-GSR: The GSR sensor provides a measure of skin resistance or skin conductance when connected to a NeXus signal acquisition device, which is influenced by the autonomic activation of sweat glands in the skin. The sensor output is not intended to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
Mind Media Europe B.V.
1.0
In Commercial Distribution

  • 08719481550073 ()


  • Skin electrical conductance meter

Blood Volume Pulse Sensor (NC-BVP-H) - 08719481550066

NC-BVP-H (head module): The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
Mind Media Europe B.V.
1.0
In Commercial Distribution

  • 08719481550066 ()


  • Photometer, reflectance

Blood Volume Pulse Sensor (NC-BVP-F) - 08719481550059

NC-BVP-F (finger module): The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
Mind Media Europe B.V.
1.0
In Commercial Distribution

  • 08719481550059 ()


  • Plethysmography phototransducer

Blood Volume Pulse Sensor (NB-BVP-H) - 08719481550042

NB-BVP-H (head module): The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
Mind Media Europe B.V.
1.0
In Commercial Distribution

  • 08719481550042 ()


  • Photometer, reflectance

Blood Volume Pulse Sensor (NB-BVP-F) - 08719481550035

NB-BVP-F (finger module): The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
Mind Media Europe B.V.
1.0
In Commercial Distribution

  • 08719481550035 ()


  • Plethysmography phototransducer

NeXus-Q32 - 08719481550004

The NeXus-Q32 is intended for acquisition of (electro)-physiological signals (e.g. EEG, surface EMG or ECG) from humans, regardless of any specific medical indication, by medical/research professionals.
Mind Media Europe B.V.
2.0
In Commercial Distribution

  • 08719481550004 ()


  • Multiple physiological signal amplifier

INTENSA - M368IN597GCOM1

RECL OB II ARM CAP COM
GF HEALTH PRODUCTS, INC.
IN597GCOM
In Commercial Distribution

  • M368IN597GCOM1 ()


  • Reclining chair

Brasseler USA - 00887919971399

K0434 PASCAL MAGNE COM/CER FIN
Peter Brasseler Holdings, LLC
5031007U0
In Commercial Distribution

  • 00887919971399 ()


  • Dental abrasive point, reusable

NAMIC - 10193489047516

MTS LEFT HEART KIT-MEDINA COM HOSP
MEDLINE INDUSTRIES, INC.
60137612
In Commercial Distribution

  • 20193489047513 ()
  • 10193489047516 ()
60137612

  • Angiography kit

NAMIC - 10193489051001

MTS LEFT HEART KIT-SOMERSET COM HOSP
MEDLINE INDUSTRIES, INC.
60193165
In Commercial Distribution

  • 20193489051008 ()
  • 10193489051001 ()
60193165

  • Angiography kit

NAMIC - 10193489050639

MTO LEFT HEART COM HOSP-SAN BERNARDINO
MEDLINE INDUSTRIES, INC.
60190792
In Commercial Distribution

  • 20193489050636 ()
  • 10193489050639 ()
60190792

  • Angiography kit

NAMIC - 10193489049909

MTS LEFT HEART KIT-HENDRICKS COM HOSP
MEDLINE INDUSTRIES, INC.
60183101
In Commercial Distribution

  • 20193489049906 ()
  • 10193489049909 ()
60183101

  • Angiography kit

CoreValve™ - 00643169565630

DEL SYS DCS-C4-18F-23US COM 23 NP
MEDTRONIC COREVALVE LLC
DCS-C4-18F-23US
Not in Commercial Distribution

  • 00643169565630 ()

  • Valve Size 23 MM


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

NAMIC - 10193489043488

MTS LEFT HEART KIT EVANGELICAL COM
MEDLINE INDUSTRIES, INC.
60052241
In Commercial Distribution

  • 20193489043485 ()
  • 10193489043488 ()
60052241

  • Angiography kit

SCHWERT - E89614071240

Bone curettes MOLT 2/4 COM
A. Schweickhardt GmbH & Co. KG
1407-124
In Commercial Distribution

  • E89614071240 ()
1407-124

  • Periosteal elevator, reusable

Marina Medical - 00840306822070

Walton Com Extr,w/o lancet"
MARINA MEDICAL INSTRUMENTS, INC.
190-157C
In Commercial Distribution

  • 00840306822070 ()
190-157C

  • Comedo expressor

NORDENT MANUFACTURING INC - 00840018647015

COM PLACM INST DE #7 DL-R
NORDENT MANUFACTURING INC
REPFI7
In Commercial Distribution

  • 00840018647015 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018637979

COM PLACMENT INST. 41T DL-CC H
NORDENT MANUFACTURING INC
CEPFI41T
In Commercial Distribution

  • 00840018637979 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018637573

COM PLACEM INSTDE, #38 TIN, DL
NORDENT MANUFACTURING INC
REPFI38T
In Commercial Distribution

  • 00840018637573 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018637566

COM PLACEM INSTDE, #37 TIN, DL
NORDENT MANUFACTURING INC
REPFI37T
In Commercial Distribution

  • 00840018637566 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018636651

COM PLACEMENT INST, #41 TiN, R
NORDENT MANUFACTURING INC
REPFI41T
In Commercial Distribution

  • 00840018636651 ()


  • Margin finishing dental file/rasp, reusable
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