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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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MEDRAD® Disposable Prostate Coil - 00616258009254

" MRInnervu Prostate Endorectal Coil, Compatible with 3.0 Tesla for GE, Siemens, and Marconi. (COIL,DISPOSABLE ENDORECTAL 3.0T,MC) (60727498)"
BAYER MEDICAL CARE INC.
BPX 30
In Commercial Distribution

  • 10616258009251 ()
  • 00616258009254 ()
BPX 30

  • MRI system coil, radio-frequency

MEDRAD® Disposable Prostate Coil - 00616258009193

" MRInnervu Prostate Endorectal Coil, Compatible with 1.5 Tesla for GE, Siemens, and Marconi. (COIL,DISPOSABLE ENDORECTAL 1.5T,MC) (60727471)"
BAYER MEDICAL CARE INC.
BPX 15
In Commercial Distribution

  • 10616258009190 ()
  • 00616258009193 ()
BPX 15

  • MRI system coil, radio-frequency

Body Bridge - 00841439106617

Slot clip for use with Siemens MR Aera, Avanto fit, Prisma, Prisma fit, Skyra, Skyra fit, Spectra and Vida
MEDTEC, INC.
MTM300210
In Commercial Distribution

  • 00841439106617 ()

  • Length: 23 Inch
MTM300210

  • Indexed-immobilization patient positioning system

Vital Care - 01618125157982

Vital Care C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case
TIDI PRODUCTS, LLC
23783
Not in Commercial Distribution

  • 00618125157983 ()
  • 01618125157982 ()


  • Medical equipment/instrument drape, single-use

MediDrapes Inc. - 01618125160913

MediDrapes Inc. C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case
TIDI PRODUCTS, LLC
30554
Not in Commercial Distribution

  • 00618125160914 ()
  • 01618125160913 ()


  • Medical equipment/instrument drape, single-use

Vital Care - 01618125158026

Vital Care C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case
TIDI PRODUCTS, LLC
24027
Not in Commercial Distribution

  • 00618125158027 ()
  • 01618125158026 ()


  • Medical equipment/instrument drape, single-use

Vital Care - 01618125157951

Vital Care C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case
TIDI PRODUCTS, LLC
23618
Not in Commercial Distribution

  • 00618125157952 ()
  • 01618125157951 ()


  • Medical equipment/instrument drape, single-use

Linearity FD Procalcitonin for Siemens Atellica - B085K814M50

No Description
AALTO SCIENTIFIC
K814M-5
In Commercial Distribution

  • B085K814M50 ()


  • Procalcitonin (PCT) IVD, control

Crook Prostate Templates 17 G Siemens - 00816389020108

No Description
Varian Medical Systems Deutschland GmbH
GM11012260
In Commercial Distribution

  • 00816389020108 ()
GM11012260

  • Vaginal brachytherapy system applicator, remote-afterloading

Smart Tray, Siemens, Solid, Lexan, Cross-Hairs - B365579010

No Description
Aktina Corp.
57-901
In Commercial Distribution

  • B365579010 ()


  • Manual-aperture-control therapeutic x-ray system collimator, non-motorized

Lateral Arm Support (Pair), Siemens Compatible - B365542260

No Description
Aktina Corp.
54-226
In Commercial Distribution

  • B365542260 ()


  • Indexed-immobilization patient positioning system

GRADIC Port Film Graticule, Siemens Compatible - B365540450

No Description
Aktina Corp.
54-045
In Commercial Distribution

  • B365540450 ()


  • X-ray film ruler

Headboard Extension, Metal Frame, Siemens Compatible - B365539880

No Description
Aktina Corp.
53-988
In Commercial Distribution

  • B365539880 ()


  • Radiological whole-body positioner

Arm Support, Vertical Adjust, Siemens Compatible - B365538970

No Description
Aktina Corp.
53-897
In Commercial Distribution

  • B365538970 ()


  • Indexed-immobilization patient positioning system

Arm Support, Dual Adjust, Siemens Compatible - B365538020

No Description
Aktina Corp.
53-802
In Commercial Distribution

  • B365538020 ()


  • Indexed-immobilization patient positioning system

Mesh Beam Block Tray, Siemens Compatible - B365531680

No Description
Aktina Corp.
53-168
In Commercial Distribution

  • B365531680 ()


  • Manual-aperture-control therapeutic x-ray system collimator, non-motorized

OP Kopfhalter LUCY Upgrade Set Siemens - 04251269205996

The NORAS OR Head Holder LUCY is used for intra-operative imaging in the X-ray or CT environment. Together with the NORAS OR head coils 1.5T/3T the head holder LUCY is used for intra-operative MR imaging during neurosurgery on the open skull.
Noras MRI products GmbH
01
In Commercial Distribution

  • 04251269205996 ()
120338

  • MRI system coil, radio-frequency

Table Docking Uni-Lift for Siemens Espree - 04251269203060

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

  • 04251269203060 ()
118667

  • MRI system coil, radio-frequency

CAB,3 LD,MRI EKG,SIEMENS - 10884838054360

No Description
Philips Ds North America LLC
989803157041
Not in Commercial Distribution

  • 10884838054360 ()
989803157041

  • Electrocardiographic lead set, reusable

Siemens Infiniti Plus Biopsy Starter Kit - 00841436111317

Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infiniti Plus™ (18, 20, 21/22, 25GA) needle guides (3), and (14 × 29.2cm) CIV-Flex™ wireless transducer covers (5) for use with Siemens C5-2 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11003356
In Commercial Distribution

  • 00841436111317 ()
  • 20841436116811 ()

  • Length: 4.1 Inch
  • Width: 1.4 Inch
11003356

  • Ultrasound imaging system tracking positioner, reusable

Siemens Infiniti Plus Biopsy Starter Kit - 00841436111300

Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infiniti Plus™ (18, 20, 21/22, 25GA) needle guides (3), and (14 × 29.2cm) CIV-Flex™ wireless transducer covers (5) for use with Siemens L13-5 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11002759
In Commercial Distribution

  • 00841436111300 ()
  • 20841436117177 ()

  • Height: 1.3 Inch
  • Length: 2.8 Inch
11002759

  • Ultrasound imaging system tracking positioner, reusable

C-ARM ADAPTER SIEMENS CIOS SPIN RIGHT - 04056481140359

No Description
Brainlab AG
19154-06
In Commercial Distribution

  • 04056481140359 ()
19154-06

  • Electromagnetic/optical surgical navigation device tracking system

C-ARM ADAPTER SIEMENS CIOS SPIN LEFT - 04056481140342

No Description
Brainlab AG
19154-05
In Commercial Distribution

  • 04056481140342 ()
19154-05

  • Electromagnetic/optical surgical navigation device tracking system

Disposable Template, 17 Gauge, Siemens, Single - 00852656007366

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
6107
In Commercial Distribution

  • 00852656007366 ()


  • Needle guide, single-use

Disposable Template, 18 Gauge, Siemens, Single - 00852656007342

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
6105
In Commercial Distribution

  • 00852656007342 ()


  • Needle guide, single-use

Siemens Draeger NIBP Hose:Adult NIBP Hose - B817AS401500

No Description
CABLES AND SENSORS, LLC
AS-40-150
In Commercial Distribution

  • B817AS401500 ()


  • Invasive blood pressure monitoring tubing set

TC-SE/SC6000 DTS INTFC CA SIEMENS - 00886333641789

Interface Cable of length 150" with a round shape, 7-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684178
In Commercial Distribution

  • 50886333641784 ()
  • 00886333641789 ()

  • cable length 150"
684178

  • Electrical-only medical device connection cable, reusable

TC-SE NLY 18IN INTFC CA SIEMENS - 00886333642403

Interface cable of 18" cable length with a round shape, 8-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684240
In Commercial Distribution

  • 50886333642408 ()
  • 00886333642403 ()

  • cable length 18"
684240

  • Electrical-only medical device connection cable, reusable

TC-SE-B DTS INTFC CA SIEMENS 300 - 00886333641208

Interface Cable of length 150" with a round shape, 5-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684120
In Commercial Distribution

  • 50886333641203 ()
  • 00886333641208 ()

  • cable length 150"
684120

  • Electrical-only medical device connection cable, reusable

ASSY,CAB,MRI ECG LDWR,SIEMENS - 00884838033757

No Description
Philips Ds North America LLC
989803153981
Not in Commercial Distribution

  • 00884838033757 ()
989803153981

  • Electrocardiographic lead set, reusable

EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI SU - 07290019402190

EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI SU w/PFK for 1 treatment for Siemens MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001116-SU (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI SU
In Commercial Distribution

  • 07290019402190 ()
SET001116-SU

  • Therapeutic oncological/gynaecological ultrasound system

InnoFine - 06971554720284

Reusable Needle Guides for use with Siemens EC9-4, EV9-4(ACUSON X150 , X300, P500, OMNI, NX2, NX3; SONOLINE G40) Ultrasound Transducers
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
JEM-029
In Commercial Distribution

  • 06971554720284 ()


  • Needle guide, reusable

Needle Guide - 10841436100400

Sterile endocavity needle guide with (2.6 x 20cm) and (3.5 x 20cm) latex covers for use with Siemens BP9-4 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10658731, 10658730
In Commercial Distribution

  • 00841436100397 ()
  • 00841436100403 ()
  • 10841436100400 ()

  • Length: 4.36 Inch
  • Height: 0.97 Inch
10658731, 10658730

  • Needle guide, single-use

Needle Guide - 10841436100264

Sterile endocavity needle guide with (2.6 x 20cm) and (3.5 x 20cm) latex covers for use with Siemens EV-8C4 transducer
CIVCO MEDICAL INSTRUMENTS CO., INC.
10136306, 676-155
In Commercial Distribution

  • 00841436100267 ()
  • 10841436100264 ()
  • 00841436107365 ()

  • Height: 1.1 Inch
  • Length: 6.1 Inch
10136306, 676-155

  • Needle guide, single-use

Needle Guide - 10841436112137

Disposable sterile endocavity needle guide with (2.6 x 20cm) and (3.5 x 20cm) latex covers for use with Siemens 10MC3
CIVCO MEDICAL INSTRUMENTS CO., INC.
11343996, 11343995-5
In Commercial Distribution

  • 00841436112130 ()
  • 10841436112137 ()
  • 00841436112154 ()

  • Width: 1.5 Inch
  • Length: 6.4 Inch
11343996, 11343995-5

  • Needle guide, single-use

Needle Guide - 10841436112038

Disposable sterile endocavity needle guide with (2.6 x 20cm) and (3.5 x 20cm) latex covers for use with Siemens BP10-3
CIVCO MEDICAL INSTRUMENTS CO., INC.
11336181, 11336181-5
In Commercial Distribution

  • 00841436112031 ()
  • 10841436112038 ()
  • 00841436112048 ()

  • Width: 1.5 Inch
  • Length: 6.4 Inch
11336181, 11336181-5

  • Needle guide, single-use

Needle Guide - 10841436107324

Sterile endocavity needle guide with (2.6 x 20cm) and (3.5 x 20cm) latex covers for use with Siemens BP9-4 transducer
CIVCO MEDICAL INSTRUMENTS CO., INC.
676-144, 10563771
In Commercial Distribution

  • 00841436107327 ()
  • 10841436107324 ()
  • 00841436100359 ()

  • Width: 1.5 Inch
  • Length: 6.4 Inch
676-144, 10563771

  • Needle guide, single-use

Needle Guide - 10841436107249

Sterile endocavity needle guide with (2 x 20cm) and (3.5 x 20cm) latex covers for use with Siemens BE9-4 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
676-110
In Commercial Distribution

  • 00841436107242 ()
  • 10841436107249 ()

  • Width: 1.5 Inch
  • Length: 6.4 Inch
676-110

  • Needle guide, single-use

Verza Guidance System - 00841436119474

Reusable non-sterile bracket with Verza guides (5) and (14 x 91.5cm) CIV-Flex covers (5) for use with Siemens 7L2 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11506900
In Commercial Distribution

  • 00841436119474 ()
  • 20841436118884 ()
11506900

  • Ultrasound imaging system tracking positioner, reusable

Needle Guide - 10841436100448

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
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