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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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4K UHD Camera System - 06971381250060

The product is composed of a 4K camera control unit, a 4K camera head, objective lens, a power cable, and video cables. Video cables contains: HD-SDI cable, HDMI cable. HD-SDI cable, HDMI cable and objective lens are optional. 4K UHD Camera System is mainly used to provide imaging of the operative area in endoscopic surgery. Do not use this system for any other purpose.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
ES-CS4K100/100C
In Commercial Distribution

  • 06971381250060 ()


  • Endoscopic video image processing unit

3D Visualization System - 06971381250053

The product is composed of a host, a foot switch and HD-SDI data cables, HDMI-DVI data cables (Foot switch, HD-SDI data cables and HDMI-DVI data cables are optional). This 3D Visualization System is intended to compose the imaging signals from video system center and convert them into 3D signals displayed on the monitor.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
3DVS-S100E
In Commercial Distribution

  • 06971381250053 ()


  • Endoscopic video image processing unit

3D Visualization System - 06971381250046

The product is composed of a host, a foot switch and HD-SDI data cables, HDMI-DVI data cables (Foot switch, HD-SDI data cables and HDMI-DVI data cables are optional). This 3D Visualization System is intended to compose the imaging signals from video system center and convert them into 3D signals displayed on the monitor.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
3DVS-S100D
In Commercial Distribution

  • 06971381250046 ()


  • Endoscopic video image processing unit

3D Visualization System - 06971381250039

The product is composed of a host, a foot switch and HD-SDI data cables, HDMI-DVI data cables (Foot switch, HD-SDI data cables and HDMI-DVI data cables are optional). This 3D Visualization System is intended to compose the imaging signals from video system center and convert them into 3D signals displayed on the monitor.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
3DVS-S100C
In Commercial Distribution

  • 06971381250039 ()


  • Endoscopic video image processing unit

3D Visualization System - 06971381250022

The product is composed of a host, a foot switch and HD-SDI data cables, HDMI-DVI data cables (Foot switch, HD-SDI data cables and HDMI-DVI data cables are optional). This 3D Visualization System is intended to compose the imaging signals from video system center and convert them into 3D signals displayed on the monitor.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
3DVS-S100B
In Commercial Distribution

  • 06971381250022 ()


  • Endoscopic video image processing unit

3D Visualization System - 06971381250015

The product is composed of a host, a foot switch and HD-SDI data cables, HDMI-DVI data cables (Foot switch, HD-SDI data cables and HDMI-DVI data cables are optional). This 3D Visualization System is intended to compose the imaging signals from video system center and convert them into 3D signals displayed on the monitor.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
3DVS-S100A
In Commercial Distribution

  • 06971381250015 ()


  • Endoscopic video image processing unit

Sample Container - 06971381257588

Bronchus Sampler is composed of the sampler connector, flow switch, silicone plug and sample container. The Bronchus Sampler is designed as accessory to the Single-use Broncho Videoscope, and intended to enable aspiration and collection of fluid sample from the bronchial or alveolar part of the lung.The sample container is used to connect to the sampler connector, and holds the retrieved sample.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
SC-60
In Commercial Distribution

  • 16971381257585 ()
  • 06971381257588 ()


  • General specimen container IVD, no additive/medium

Bronchus Sampler - 06971381257144

Bronchus Sampler is composed of the sampler connector, flow switch, silicone plug and sample container. The Bronchus Sampler is designed as accessory to the Single-use Broncho Videoscope, and intended to enable aspiration and collection of fluid sample from the bronchial or alveolar part of the lung.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
BS-6060
In Commercial Distribution

  • 16971381257141 ()
  • 06971381257144 ()


  • General specimen container IVD, no additive/medium

Single-use Broncho Videoscope - 06971381254723

The product is composed of a distal end, a bending section, an insertion section, an operation section, and a plug section. This Single-use Broncho Videoscope is intended to use in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of respiratory system such as trachea, bronchi, and lungs.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
SBV-1C-P
In Commercial Distribution

  • 16971381254720 ()
  • 06971381254723 ()


  • Flexible video bronchoscope, single-use

Single-use Broncho Videoscope - 06971381254716

The product is composed of a distal end, a bending section, an insertion section, an operation section, and a plug section. This Single-use Broncho Videoscope is intended to use in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of respiratory system such as trachea, bronchi, and lungs.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
SBV-1C-B
In Commercial Distribution

  • 16971381254713 ()
  • 06971381254716 ()


  • Flexible video bronchoscope, single-use

Single-use Broncho Videoscope - 06971381254693

The product is composed of a distal end, a bending section, an insertion section, an operation section, and a plug section. This Single-use Broncho Videoscope is intended to use in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of respiratory system such as trachea, bronchi, and lungs.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
SBV-1B-B
In Commercial Distribution

  • 16971381254690 ()
  • 06971381254693 ()


  • Flexible video bronchoscope, single-use

Single-use Broncho Videoscope - 06971381254686

The product is composed of a distal end, a bending section, an insertion section, an operation section, and a plug section. This Single-use Broncho Videoscope is intended to use in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of respiratory system such as trachea, bronchi, and lungs.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
SBV-1A-P
In Commercial Distribution

  • 16971381254683 ()
  • 06971381254686 ()


  • Flexible video bronchoscope, single-use

Single-use Broncho Videoscope - 06971381254679

The proposed device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope and an Endoscopic Image Processor including the foot switch. The proposed device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi and lungs.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
SBV-1A-B
In Commercial Distribution

  • 16971381254676 ()
  • 06971381254679 ()


  • Flexible video bronchoscope, single-use

Shear Wave Quantificational Ultrasound Diagnostic System - 06971679949072

No Description
Wuxi Hisky Medical Technologies Co.,Ltd.
Mini800
In Commercial Distribution

  • 06971679949072 ()


  • Hepatic ultrasound elastography system

Shear Wave Quantificational Ultrasound Diagnostic System - 06971679949065

No Description
Wuxi Hisky Medical Technologies Co.,Ltd.
FT100
In Commercial Distribution

  • 06971679949065 ()


  • Hepatic ultrasound elastography system

Fibrosis Scanning Probe - 06971679947023

No Description
Wuxi Hisky Medical Technologies Co.,Ltd.
FT-2.5D9
In Commercial Distribution

  • 06971679947023 ()


  • Hepatic ultrasound elastography system applicator

Imaging Probe - 06971679947016

No Description
Wuxi Hisky Medical Technologies Co.,Ltd.
FT-3.5R65
In Commercial Distribution

  • 06971679947016 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

Shear Wave Quantificational Ultrasound Diagnostic System - 06971679945005

No Description
Wuxi Hisky Medical Technologies Co.,Ltd.
FT9000
In Commercial Distribution

  • 06971679945005 ()


  • Hepatic ultrasound elastography system

InTouch - 07613327385427

No Description
STRYKER CORPORATION
2141
In Commercial Distribution

  • 07613327385427 ()
2141-PX2-000

  • Basic electric hospital bed

Power-LOAD - 07613327394740

No Description
STRYKER CORPORATION
6390
In Commercial Distribution

  • 07613327394740 ()
639005550001

  • Ambulance stretcher loader

Isolibrium - 07613327390049

No Description
STRYKER CORPORATION
2972
Not in Commercial Distribution

  • 07613327390049 ()
297205550001

  • Flotation therapy bed, adult

SurgiCount - 07613327625882

+ Stand 3.0
STRYKER CORPORATION
0894002001
In Commercial Distribution

  • 07613327625882 ()
0894-002-001

  • Surgical sponge-counting rack

SurgiCount - 07613327623079

+ PD Wall Mount
STRYKER CORPORATION
0894002003
In Commercial Distribution

  • 07613327623079 ()
0894-002-003

  • Electronic surgical sponge-counter

Prime Series - 07613327622690

1105-000-000C
STRYKER CORPORATION
1105
In Commercial Distribution

  • 07613327622690 ()
1105-000-000C

  • Hospital stretcher, manual

Emerg® Auto-Emersiontherapy - B267E10000

Emerg Auto-Emersiontherapy is a powered mattress replacement system that automatically customizes surface immersion specific to the patient's therapy needs, creating a fluid-like, pressure environment for wound healing.
ETS MANUFACTURING, INC.
E1000
In Commercial Distribution

  • B267E10000 ()
10008015

  • Flotation therapy bed, adult

Prime Series - 07613327613650

1125-000-000C
STRYKER CORPORATION
1125
In Commercial Distribution

  • 07613327613650 ()
1125-000-000C

  • Hospital stretcher, powered

Prime Series - 07613327613643

1115-000-000C
STRYKER CORPORATION
1115
In Commercial Distribution

  • 07613327613643 ()
1115-000-000C

  • Hospital stretcher, manual

S3 - 07613327347449

No Description
STRYKER CORPORATION
3005
In Commercial Distribution

  • 07613327347449 ()
3005S3HT1

  • Basic electric hospital bed

Prime - 07613327347500

No Description
STRYKER CORPORATION
1115EHT2
In Commercial Distribution

  • 07613327347500 ()
1115EHT2

  • Hospital stretcher, manual

Prime - 07613327347494

No Description
STRYKER CORPORATION
1115EHT1
In Commercial Distribution

  • 07613327347494 ()
1115EHT1

  • Hospital stretcher, manual

Prime - 07613327347487

No Description
STRYKER CORPORATION
1115MHT2
In Commercial Distribution

  • 07613327347487 ()
1115MHT2

  • Hospital stretcher, manual

Prime - 07613327347470

No Description
STRYKER CORPORATION
1115MHT1
In Commercial Distribution

  • 07613327347470 ()
1115MHT1

  • Hospital stretcher, manual

Prime Series - 07613327347463

No Description
STRYKER CORPORATION
1105MHT1
In Commercial Distribution

  • 07613327347463 ()
1105MHT1

  • Hospital stretcher, manual

SURGICOUNT - 07613327519525

+ STAND
STRYKER CORPORATION
0694002001
In Commercial Distribution

  • 07613327519525 ()
0694-002-001

  • Surgical sponge-counting rack

SURGICOUNT - 07613327519518

+ CRADLE WALL MOUNT
STRYKER CORPORATION
0694002003
In Commercial Distribution

  • 07613327519518 ()
0694-002-003

  • Electronic surgical sponge-counter

IsoTour - 07613327515961

No Description
STRYKER CORPORATION
2872
In Commercial Distribution

  • 07613327515961 ()
2872-000-022

  • Gel-filled bed mattress
  • Alternating-pressure bed mattress overlay system

IsoTour - 07613327515954

No Description
STRYKER CORPORATION
2872
In Commercial Distribution

  • 07613327515954 ()
2872-000-021

  • Gel-filled bed mattress
  • Alternating-pressure bed mattress overlay system

SURGICOUNT - 07613327515855

+ READER
STRYKER CORPORATION
0694002005
In Commercial Distribution

  • 07613327515855 ()
0694-002-005

  • Electronic surgical sponge-counter

SURGICOUNT - 07613327513295

+ CRADLE
STRYKER CORPORATION
0694002002
In Commercial Distribution

  • 07613327513295 ()
0694-002-002

  • Electronic surgical sponge-counter

Power PRO - 07613327513288

No Description
STRYKER CORPORATION
6506
In Commercial Distribution

  • 07613327513288 ()
650605550001

  • Ambulance stretcher, electrohydraulic

NA - 07613327509373

ELITE 7CM MODIFIED ANGLED ATTACHMENT
STRYKER CORPORATION
5407-120-442
In Commercial Distribution

  • 07613327509373 ()
5407-120-442

  • Drilling power tool attachment, basic

iBur - 07613327509229

3.0mm DIAMOND MATCH HEAD, DISTAL BEND
STRYKER CORPORATION
8431-107-030D
In Commercial Distribution

  • 07613327509229 ()
8431-107-030D

  • Cranial bur, single-use

Power-PRO 2 - 07613327504460

No Description
STRYKER CORPORATION
650700000000
In Commercial Distribution

  • 07613327504460 ()
650700000000

  • Ambulance stretcher, electrohydraulic

Power-LOAD - 07613327504453

No Description
STRYKER CORPORATION
639005550003
In Commercial Distribution

  • 07613327504453 ()
639005550003

  • Gel-filled bed mattress

NA - 07613327504057

PI DRIVE 2 PLUS MOTOR
STRYKER CORPORATION
5407-350-000
In Commercial Distribution

  • 07613327504057 ()
5407-350-000

  • Bone/joint surgical power tool motor, electric

NA - 07613327504040

NON FOOTED ATTACHMENT 8CM
STRYKER CORPORATION
5407-NF2-8CM
In Commercial Distribution

  • 07613327504040 ()
5407-NF2-8CM

  • Drilling power tool attachment, basic

NA - 07613327504033

NON FOOTED ATTACHMENT 9CM
STRYKER CORPORATION
5407-NF2-9CM
In Commercial Distribution

  • 07613327504033 ()
5407-NF2-9CM

  • Drilling power tool attachment, basic

NA - 07613327504026

ELITE 7CM MODIFIED STRAIGHT ATTACHMENT
STRYKER CORPORATION
5407-120-440
In Commercial Distribution

  • 07613327504026 ()
5407-120-440

  • Drilling power tool attachment, basic

NA - 07613327504019

PI DRIVE 2 MOTOR
STRYKER CORPORATION
5407-150-000
In Commercial Distribution

  • 07613327504019 ()
5407-150-000

  • Bone/joint surgical power tool motor, electric

IsoAir - 07613327503999

No Description
STRYKER CORPORATION
2941
In Commercial Distribution

  • 07613327503999 ()
2941-001-100

  • Alternating-pressure bed mattress overlay system
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