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

  • 10884838054360 ()
989803157041

  • Electrocardiographic lead set, 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 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
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
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
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
No Description
Philips Ds North America LLC
989803153981
Not in Commercial Distribution

  • 00884838033757 ()
989803153981

  • Electrocardiographic lead set, reusable
" 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
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
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
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 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
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
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
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
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
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
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
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
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
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
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
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
" MRInnervu Prostate Endorectal Coil, Compatible with 1.5 Tesla for GE, Siemens, and Marconi. (1.5T PROSTATE eCOIL 50 IN A BOX) (60727501)"
BAYER MEDICAL CARE INC.
BPX15-50
In Commercial Distribution

  • 10616258009206 ()
  • 00616258009209 ()
BPX15-50

  • MRI system coil, radio-frequency
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