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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Sterile endocavity needle guide with (2.6 x 20cm) and (3.5 x 20cm) latex covers for use with Siemens EC9-4w, MC9-4 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10659482, 10658880
In Commercial Distribution

  • 00841436100441 ()
  • 10841436100448 ()
  • 00841436100427 ()

  • Height: 1.05 Inch
  • Length: 6.16 Inch
10659482, 10658880

  • Needle guide, single-use
Reusable non-sterile bracket with Verza guides (5) and (14 x 91.5cm) CIV-Flex covers (5) for use with Siemens Healtineers 13L4 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11502761
In Commercial Distribution

  • 20841436118877 ()
  • 00841436119023 ()

  • Width: 1.1 Inch
  • Length: 2.4 Inch
11502761

  • Ultrasound imaging system tracking positioner, reusable
Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 6C2 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10441190
In Commercial Distribution

  • 00841436100328 ()
  • 20841436117771 ()

  • Width: 1.17 Inch
  • Length: 3.48 Inch
10441190

  • Electromagnetic surgical navigation device tracking system
Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 4V1 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10441188
In Commercial Distribution

  • 00841436100304 ()
  • 20841436117382 ()

  • Height: 1.37 Inch
  • Length: 2.15 Inch
10441188

  • Electromagnetic surgical navigation device tracking system
for use with Siemens TXT or Proutra™ with Lok-Bar™, Prodigy™*2 Head Extension, rectangular extension, and storage rack
MEDTEC, INC.
MTIL6040
In Commercial Distribution

  • 00841439105344 ()
MTIL6040

  • Indexed-immobilization patient positioning system
Sterile endocavity needle guide for use with Siemens EC9-4 and EV9-4 (on G40, Acuson X150, X300) and Samsung Medison EA2-11B transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
676-132
In Commercial Distribution

  • 00841436107297 ()
  • 10841436107294 ()

  • Height: 0.98 Inch
  • Length: 5.15 Inch
676-132

  • Needle guide, single-use
No Description
Opsens Inc
AUX interface cable - Siemens Vibe AO2
In Commercial Distribution

  • 07540184011186 ()
F201118

  • Cardiac catheterization laboratory computer
Siemens Artis Zee SheerCare Replacement Table Pad Set. The SheerCare Series is a dense supportive foam with a 4 way stretch covering.
David Scott Company
BB-SIE-ART-ZEE-SG
In Commercial Distribution

  • 15060797550807 ()

  • Length: 107 Inch
  • Width: 26 Inch
BB-SIE-ART-ZEE-SG

  • Operating table patient pressure distribution pad, reusable
Reusable Needle Guides for use with Canon PVF-641VT, PVM-651VT, PVN-661VT, PVQ-641V, PVT-661VT, PVG-630v; Siemens EC9-4(ACUSON S1000, S2000, S3000, Antares) Ultrasound Transducers
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
JEM-018
In Commercial Distribution

  • 06971554720185 ()


  • Needle guide, reusable
No Description
Brainlab AG
41860-22
Not in Commercial Distribution

  • 04056481003029 ()
41860-22

  • Robotic surgical navigation system
No Description
THE BINDING SITE GROUP LIMITED
NK626.T.A
In Commercial Distribution

  • 05051700017008 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
NK625.T.A
In Commercial Distribution

  • 05051700016995 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
NK622.T.A
In Commercial Distribution

  • 05051700016988 ()


  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
NK621.T.A
In Commercial Distribution

  • 05051700016971 ()


  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
NK624.T.A
In Commercial Distribution

  • 05051700016926 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
The Disposable Template, when used in conjunction with a reusable frame, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
Best Nomos
6049
In Commercial Distribution

  • 00852656007250 ()


  • Needle guide, single-use
The Disposable Template, when used in conjunction with a reusable frame, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
Best Nomos
6047
In Commercial Distribution

  • 00852656007236 ()


  • Needle guide, single-use
The Civco/BW Stepper Reusable Frame, when used in conjunction with a disposable template, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
Best Nomos
6053
In Commercial Distribution

  • 00852656007205 ()


  • Needle guide, reusable
Ecoil ID - FID SYM
DXTX MEDICAL INC
FID SYM
In Commercial Distribution

  • 00850011472200 ()


  • MRI system coil, radio-frequency
No Description
Aktina Corp.
56-053
In Commercial Distribution

  • B365560530 ()


  • Indexed-immobilization patient positioning system
No Description
Aktina Corp.
52-950
In Commercial Distribution

  • B365529500 ()


  • Radiation therapy port film device
No Description
AALTO SCIENTIFIC
K893M-5
In Commercial Distribution

  • B085K893M50 ()


  • D-dimer IVD, control
No Description
AALTO SCIENTIFIC
K892M-5
In Commercial Distribution

  • B085K892M50 ()


  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
No Description
AALTO SCIENTIFIC
K891M-5
In Commercial Distribution

  • B085K891M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K802M-5
In Commercial Distribution

  • B085K802M50 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
AALTO SCIENTIFIC
K813M-5
In Commercial Distribution

  • B085K813M50 ()


  • Parathyroid hormone (PTH) IVD, control
No Description
AALTO SCIENTIFIC
K809M-5
In Commercial Distribution

  • B085K809M50 ()


  • Multiple anaemia-related analyte IVD, control
No Description
AALTO SCIENTIFIC
K808M-5
In Commercial Distribution

  • B085K808M50 ()


  • Multiple human hormone IVD, control
No Description
AALTO SCIENTIFIC
K801M-5
In Commercial Distribution

  • B085K801M50 ()


  • Homocysteine IVD, control
The Uni-Lift is used for aiding MR guided prostate interventions such as prostate biopsy or therapy.
Noras MRI products GmbH
01
In Commercial Distribution

  • 04251269203039 ()
118331

  • MRI system coil, radio-frequency
Medical equipment drape, single-use
PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.
4130
In Commercial Distribution

  • 00836230002138 ()
  • 01836230002137 ()
  • 02836230002136 ()


  • Medical equipment/instrument drape, single-use
12' (3.6M) REUSABLE TEMP ADAPTER CABLE WITH 7 PIN DIN CONNECTOR FOR DRAEGER INFINITY/ SIEMENS SC SERIES PATIENT MONITORS & 400 SERIES TEMPERATURE PROBES.
NOVAMED-USA INC.
11-CA-407-12
In Commercial Distribution

  • 00817499020576 ()


  • Electrical-only medical device connection cable, reusable
4' (1.2M) REUSABLE TEMPERATURE ADAPTER CABLE WITH 7 PIN DIN CONNECTOR FOR DRAEGER INFINITY/ SIEMENS SC SERIES PATIENT MONITORS & 400 SERIES TEMPERATURE PROBES.
NOVAMED-USA INC.
11-CA-407-04
In Commercial Distribution

  • 00817499020569 ()


  • Electrical-only medical device connection cable, reusable
Disposable Needle Guides Kit for endocavity biopsy, contents: Needle guide use with Siemens 10MC3 ultrasound transducers; 20g gel; 5x30cm latex cover, rubber bands.
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
DEK-042
In Commercial Distribution

  • 16975122553479 ()
  • 06975122553472 ()
11347

  • Needle guide, single-use
Disposable Needle Guides Kit for endocavity biopsy, contents: Needle guide use with Siemens BP10-3 ultrasound transducers; 20g gel; 5x30cm latex cover, rubber bands.
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
DEK-041
In Commercial Distribution

  • 16975122553462 ()
  • 06975122553465 ()
11346

  • Needle guide, single-use
System for non-invasive tumor ablation within head through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS) for Siemens MRI scanners.
INSIGHTEC LTD
SYS0004000-BA 4000 Type 1.1
In Commercial Distribution

  • 07290015461092 ()

  • Weight: 1700 Kilogram
EXABLATE 4000 Type 1.1

  • Therapeutic oncological/gynaecological ultrasound system
Disposable Needle Guides for use with Canon PVF-641VT, PVM-651VT, PVN-661VT, PVQ-641V, PVT-661VT; Siemens EC9-4(ACUSON S1000, S2000, S3000 and SONOLINE Antares) Ultrasound Transducers
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
DE-008
In Commercial Distribution

  • 16971554725088 ()
  • 06971554725081 ()
DE-008

  • Needle guide, single-use
Adapter Blood Pressure Cuff Y 1-Tube Luer Lock To 2-Tube Screw Cuff For Datascope Siemens Monitors Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
M9231
In Commercial Distribution

  • 50885632131576 ()


  • Blood pressure cuff, reusable
Reusable non-sterile bracket with Verza™ guides (5), (14x91.5cm) CIV-Flex™ covers (5), and cleaning brushes (5) for use with Siemens Healthineer 14L4 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11504106
In Commercial Distribution

  • 20841436120528 ()
  • 00841436121569 ()
11504106

  • Ultrasound imaging system tracking positioner, reusable
Reusable non-sterile bracket with Verza™ guides (5) and (14x91.5cm) CIV-Flex™ covers (5), for use with Siemens Healthineers 14L5 (Model No. 11254090) transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11287650
In Commercial Distribution

  • 00841436112185 ()
  • 20841436115838 ()
11287650

  • Ultrasound imaging system tracking positioner, reusable
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