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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Medvision C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case
TIDI PRODUCTS, LLC
28891
Not in Commercial Distribution

  • 00618125161089 ()
  • 01618125161088 ()


  • Medical equipment/instrument drape, single-use
OEC C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case
TIDI PRODUCTS, LLC
24810
Not in Commercial Distribution

  • 01618125158286 ()


  • Medical equipment/instrument drape, single-use
HeffMed C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case
TIDI PRODUCTS, LLC
28440
Not in Commercial Distribution

  • 00618125157471 ()
  • 01618125157470 ()


  • Medical equipment/instrument drape, single-use
Drapetech C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case
TIDI PRODUCTS, LLC
28486
Not in Commercial Distribution

  • 01618125157418 ()


  • Urological fluid funnel, sterile
BIOCOMMERCIALE C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case
TIDI PRODUCTS, LLC
29655
Not in Commercial Distribution

  • 01618125155575 ()


  • Medical equipment/instrument drape, single-use
SteriGear C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case
TIDI PRODUCTS, LLC
29412
Not in Commercial Distribution

  • 01618125155551 ()


  • Medical equipment/instrument drape, single-use
SteriGear C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case
TIDI PRODUCTS, LLC
27295
Not in Commercial Distribution

  • 01618125155421 ()


  • Urological fluid funnel, sterile
SteriGear C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case
TIDI PRODUCTS, LLC
27294
Not in Commercial Distribution

  • 01618125155414 ()


  • Urological fluid funnel, sterile
OEC C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case
TIDI PRODUCTS, LLC
24808
Not in Commercial Distribution

  • 01618125152246 ()


  • Medical equipment/instrument drape, single-use
OEC C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case
TIDI PRODUCTS, LLC
20768
Not in Commercial Distribution

  • 01618125152215 ()


  • Medical equipment/instrument drape, single-use
OEC C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case
TIDI PRODUCTS, LLC
20767
Not in Commercial Distribution

  • 01618125152208 ()


  • Medical equipment/instrument drape, single-use
Gems C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case
TIDI PRODUCTS, LLC
20493
Not in Commercial Distribution

  • 01618125152055 ()


  • Medical equipment/instrument drape, single-use
TIDIShield C-arm Equipment Covers Green Kit Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case
TIDI PRODUCTS, LLC
5429
Not in Commercial Distribution

  • 01618125140106 ()


  • Medical equipment/instrument drape, single-use
Sterile (15.2 tapered to 7.6 x 183cm) polyethylene accordion-folded cover for use with Siemens AcuNav ultrasound catheter family connector
CIVCO MEDICAL INSTRUMENTS CO., INC.
612-113
In Commercial Distribution

  • 00841436104869 ()
  • 10841436104866 ()

  • Width: 15.2 Centimeter
  • Length: 183 Centimeter
612-113

  • Medical equipment/instrument drape, single-use
Sterile endocavity needle guide for use with Siemens EC7, EC9-4 (SONOLINE G20, G50, G60 S, X500) and EC-10C5 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
612-061
In Commercial Distribution

  • 00841436104814 ()
  • 10841436104811 ()

  • Height: 0.909 Inch
  • Length: 4.63 Inch
612-061

  • Needle guide, single-use
" 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
" 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
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
EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI w/PFK for 5 treatments for Siemens MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001116 (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI
In Commercial Distribution

  • 07290019402183 ()
SET001116

  • Therapeutic oncological/gynaecological ultrasound system
EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI w/PFK for 1 treatment for Siemens MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001113-SU (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI
In Commercial Distribution

  • 07290019402138 ()
SET001113-SU

  • Therapeutic oncological/gynaecological ultrasound system
EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI w/PFK for 5 treatments for Siemens MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001113 (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI
In Commercial Distribution

  • 07290019402121 ()
SET001113

  • Therapeutic oncological/gynaecological ultrasound system
Disposable Needle Guides for use with Samsung EA2-11B; Siemens EC9-4, EV9-4(SONOLINE G40, X150, X300; Terason 8EC4A Ultrasound Transducers
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
DE-021
In Commercial Distribution

  • 16971554725217 ()
  • 06971554725210 ()
DE-021

  • Needle guide, single-use
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 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 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
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
No Description
CABLES AND SENSORS, LLC
AS-40-150
In Commercial Distribution

  • B817AS401500 ()


  • Invasive blood pressure monitoring tubing set
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
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
No Description
Philips Ds North America LLC
989803157041
Not in Commercial Distribution

  • 10884838054360 ()
989803157041

  • Electrocardiographic lead set, reusable
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
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
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
No Description
Brainlab AG
19154-06
In Commercial Distribution

  • 04056481140359 ()
19154-06

  • Electromagnetic/optical surgical navigation device tracking system
No Description
Brainlab AG
19154-05
In Commercial Distribution

  • 04056481140342 ()
19154-05

  • Electromagnetic/optical surgical navigation device tracking system
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
No Description
AALTO SCIENTIFIC
K814M-5
In Commercial Distribution

  • B085K814M50 ()


  • Procalcitonin (PCT) IVD, control
No Description
Aktina Corp.
57-901
In Commercial Distribution

  • B365579010 ()


  • Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
Aktina Corp.
54-226
In Commercial Distribution

  • B365542260 ()


  • Indexed-immobilization patient positioning system
No Description
Aktina Corp.
54-045
In Commercial Distribution

  • B365540450 ()


  • X-ray film ruler
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