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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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B100 SERIES - B1001011

B100 SERIES PULSE OXIMETER SENSOR
BETA BIOMED SERVICES INC
B100-1011
In Commercial Distribution

  • B100101103 ()
  • B1001011 ()


  • Pulse oximeter, line-powered

Aligned Medical Solutions - B09U8AMS12278B0

BODY PACK
Aligned Medical Solutions
AMS12278B
In Commercial Distribution

  • AMS12278B1 ()
  • B09U8AMS12278B0 ()
AMS12278B

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

Aligned Medical Solutions - B09R402C0

Myelogram Kit - RX
Aligned Medical Solutions
R402C
In Commercial Distribution

  • B098R402C1 ()
  • B09R402C0 ()
R402C

  • General surgical procedure kit, medicated

Aligned Medical Solutions - B09AMS3549C0

Arthroscopy Pack
Aligned Medical Solutions
AMS3549C
In Commercial Distribution

  • B098AMS3549C1 ()
  • B09AMS3549C0 ()
AMS3549C

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

Aligned Medical Solutions - B09AMS165960

Tonsil Pack
Aligned Medical Solutions
AMS16596
In Commercial Distribution

  • B098AMS165961 ()
  • B09AMS165960 ()
AMS16596

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

Aligned Medical Solutions - B09AMS164740

General Purpose Tray
Aligned Medical Solutions
AMS16474
In Commercial Distribution

  • B098AMS164741 ()
  • B09AMS164740 ()
AMS16474

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

Aligned Medical Solutions - B09AMS14777A0

Cataract Pack
Aligned Medical Solutions
AMS14777A
In Commercial Distribution

  • B098AMS14777A1 ()
  • B09AMS14777A0 ()
AMS14777A

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

Aligned Medical Solutions - B09AMS13807A0

Abdominoplasty Pack
Aligned Medical Solutions
AMS13807A
In Commercial Distribution

  • B098AMS13807A1 ()
  • B09AMS13807A0 ()
AMS13807A

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

CURE LP - B167S1900455000

No Description
MEDITECH SPINE, LLC
S1-900-455-00
In Commercial Distribution

  • B167S1900455000 ()
  • B167S2900455001 ()


  • Intraoperative orthopaedic bone pin/screw, single-use

CapnoVue - B1824737TG700

No Description
SALTER LABS
2002-A 4737TG-7-0-50
In Commercial Distribution

  • B1824737TG70503 ()
  • B1824737TG700 ()


  • Rebreathing oxygen face mask

CapnoVue - B18247371400

No Description
SALTER LABS
2004-A 4737-14-0-50
In Commercial Distribution

  • B1824737140503 ()
  • B18247371400 ()


  • Rebreathing oxygen face mask

CapnoVue - B1824727TG700

No Description
SALTER LABS
1002-A 4727TG-7-0-50
In Commercial Distribution

  • B1824727TG70503 ()
  • B1824727TG700 ()


  • Rebreathing oxygen face mask

CapnoVue - B18247271400

No Description
SALTER LABS
1004-A 4727-14-0-50
In Commercial Distribution

  • B18247271400 ()
  • B1824727140503 ()


  • Rebreathing oxygen face mask

Capnovue - B1822001P0

No Description
SALTER LABS
2001-P
In Commercial Distribution

  • B1822001P0 ()
  • B1822001P503 ()


  • Rebreathing oxygen face mask

Capnovue - B1822001A0

No Description
SALTER LABS
2001-A
In Commercial Distribution

  • B1822001A503 ()
  • B1822001A0 ()


  • Rebreathing oxygen face mask

Capnovue - B1821001P0

No Description
SALTER LABS
1001-P
In Commercial Distribution

  • B1821001P503 ()
  • B1821001P0 ()


  • Rebreathing oxygen face mask

Capnovue - B1821001I0

No Description
SALTER LABS
1001-I
In Commercial Distribution

  • B1821001I0 ()
  • B1821001I503 ()


  • Rebreathing oxygen face mask

Capnovue - B1821001A0

No Description
SALTER LABS
1001-A
In Commercial Distribution

  • B1821001A0 ()
  • B1821001A503 ()


  • Rebreathing oxygen face mask

TMJOINT - B179TMJ

BTS TMJOINT is a wireless surface electromyograph to measure the differential influence of the occlusal function through indices validated and published in scientific literature
BTS SPA
1.0
In Commercial Distribution

  • B179TMJ1 ()
  • B179TMJ ()
BTSEMB1BM

  • Electromyograph

TEETHAN - B179THN2

Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system To measure relative (intra-patient) levels of activity of 2 muscles during a functional act
BTS SPA
2.0
In Commercial Distribution

  • B179THN1 ()
  • B179THN2 ()
BTSEMB1BM

  • Electromyograph

G-SENSOR - B179GSN2

BTS G-SENSOR 2 is a wireless system consisting of an inertial sensor composed by a tri-axial accelerometer, a magnetic sensor, and a tri-axial gyroscope, that worn by the patient allows a functional gait analysis.
BTS SPA
2
In Commercial Distribution

  • B179GSN2 ()
  • B179GSN21 ()
BTSGSN2

  • Gait analysis system

FREEEMG - B179FR1

BTS FREEEMG 1000 is a wireless surface electromyograph for the acquisition and transmission of EMG signals and for the assessment of angles, angular velocities, angular accelerations and foot-floor contact areas. It allows the functional evaluation and a real-time visualization of the acquired signals for biofeedback and monitoring applications.
BTS SPA
1000
In Commercial Distribution

  • B179FR11 ()
  • B179FR1 ()
BTSEMB1BM

  • Electromyograph

FREEEMG - B179FE3

BTS FREEEMG 300 is a wireless surface electromyograph, which makes the selection of muscles, the setting of duration and frequency of acquisition, amplification gain and the correct positioning of electrodes, simple and rapid.
BTS SPA
300
In Commercial Distribution

  • B179FE31 ()
  • B179FE3 ()
BTSFE3

  • Electromyograph

baiobit - B179BAIO1

BAIOBIT is a wireless system consisting of an inertial sensor composed by a tri-axial accelerometer, a magnetic sensor, and a tri-axial gyroscope, that worn by the patient allows a functional movement analysis.
BTS SPA
1
In Commercial Distribution

  • B179BAIO11 ()
  • B179BAIO1 ()


  • Gait analysis system

Shiga Toxin Direct Test - B178GBSTEC100

Shiga Toxin Direct Test Cartridge with sample prep device.
GREAT BASIN SCIENTIFIC, INC.
GBSTEC-10
In Commercial Distribution

  • B178GBSTEC102 ()
  • B178GBSTEC100 ()
GBSTEC-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Staph ID/R Blood Culture Panel - B178GBSIDR100

No Description
GREAT BASIN SCIENTIFIC, INC.
GBSIDR-10
In Commercial Distribution

  • B178GBSIDR102 ()
  • B178GBSIDR100 ()
GBSIDR-10

  • MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)
  • MRSE nucleic acid detection IVD, kit, nucleic acid technique (NAT)
  • Multiple Staphylococcus bacterial species culture isolate identification IVD, kit
  • MRSA nucleic acid IVD, kit, nucleic acid technique (NAT)

Stool Bacterial Pathogens Panel - B178GBSBPP100

Stool Bacterial Pathogens Panel Cartridge with sample prep device.
GREAT BASIN SCIENTIFIC, INC.
GBSBPP-10
In Commercial Distribution

  • B178SBPP102 ()
  • B178GBSBPP100 ()
GBSBPP-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

Group B Strep Assay - B178GBGBS100

No Description
GREAT BASIN SCIENTIFIC, INC.
GBGBS-10
In Commercial Distribution

  • B178GBGBS100 ()
  • B178GBGBS102 ()
GBGBS-10

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Portrait Toxigenic C. difficile Assay - B178GBCDIFF100

C. diff Assay Cartridge and Sample Prep Device.
GREAT BASIN SCIENTIFIC, INC.
GBCDIFF-10
In Commercial Distribution

  • B178GBCDIFF100 ()
  • B178GBCDIFF102 ()
GBCDIFF-10

  • Clostridium difficile toxin B nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Bordetella Direct Test - B178GBBORD100

Bordetella Direct Test Cartridge
GREAT BASIN SCIENTIFIC, INC.
GBBORD-10
In Commercial Distribution

  • B178GBBORD100 ()
  • B178GBBORD102 ()
GBBORD-10

  • Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT)

Accu-Beam - B177AC1069640010

Cleaning Brush - 550mm x 1.524mm
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
AC-1069640-1
In Commercial Distribution

  • B177AC1069640013 ()
  • B177AC1069640010 ()


  • Surgical irrigation/aspiration handpiece, reusable

Accu-Beam - B177911102030

Rear cap for 11ga fiberoptic handpiece.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
9111-0203
In Commercial Distribution

  • B177911102030 ()
  • B177911102033 ()


  • General/multiple surgical laser system beam guide, reusable

Accu-Beam - B177911102020

Rear cap for 14ga fiberoptic handpiece.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
9111-0202
In Commercial Distribution

  • B177911102020 ()
  • B177911102023 ()


  • General/multiple surgical laser system beam guide, reusable

Accu-Beam - B177911102010

Rear cap for 16ga fiberoptic handpiece.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
9111-0201
In Commercial Distribution

  • B177911102010 ()
  • B177911102013 ()


  • General/multiple surgical laser system beam guide, reusable

Accu-Beam - B17720502350

Silicone gripper for 11ga fiberoptic handpiece.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
205-023-5
In Commercial Distribution

  • B17720502350 ()
  • B17720502353 ()


  • General/multiple surgical laser system beam guide, reusable

Accu-Beam - B17720502330

Silicone gripper for 14ga fiberoptic handpiece.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
205-023-3
In Commercial Distribution

  • B17720502330 ()
  • B17720502333 ()


  • General/multiple surgical laser system beam guide, reusable

Accu-Beam - B17720502310

Silicone gripper for 16ga fiberoptic handpiece.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
205-023-1
In Commercial Distribution

  • B17720502310 ()
  • B17720502313 ()


  • General/multiple surgical laser system beam guide, reusable

CURE LP - B167S1700455000

No Description
MEDITECH SPINE, LLC
S1-700-455-00
In Commercial Distribution

  • B167S2700455001 ()
  • B167S1700455000 ()


  • Intraoperative orthopaedic bone pin/screw, single-use

Accu-Beam - B17791010030

Cleaning Brush - 890 L x 1.7mm OD x 25mm brush face
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
91010-03
In Commercial Distribution

  • B17791010030 ()
  • B17791010033 ()


  • Surgical irrigation/aspiration handpiece, reusable

Aligned Medical Solutions - B098CMP1768A0

Embryo Transfer Pack
Aligned Medical Solutions
CMP1768A
In Commercial Distribution

  • B098CMP1768A1 ()
  • B098CMP1768A0 ()
CMP1768A

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