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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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i-ED COIL - 04540778177208

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-1040
In Commercial Distribution

  • 04540778177208 ()

  • Complex (Medium Soft) 14inch 10mm x 40cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-1040

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177185

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0940
In Commercial Distribution

  • 04540778177185 ()

  • Complex (Soft) 14inch 9mm x 40cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-0940

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177154

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0840
In Commercial Distribution

  • 04540778177154 ()

  • Complex (Soft) 14inch 8mm x 40cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-0840

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177123

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0730
In Commercial Distribution

  • 04540778177123 ()

  • Complex (Soft) 12inch 7mm x 30cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-0730

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177093

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0620
In Commercial Distribution

  • 04540778177093 ()

  • Complex (Soft) 12inch 6mm x 20cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-0620

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177079

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0515
In Commercial Distribution

  • 04540778177079 ()

  • Complex (Soft) 12inch 5mm x 15cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-0515

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177055

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0510
In Commercial Distribution

  • 04540778177055 ()

  • Complex (Soft) 12inch 5mm x 10cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-0510

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177048

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0410
In Commercial Distribution

  • 04540778177048 ()

  • Complex (Soft) 10inch 4mm x 10cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
392-0410

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778177017

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-03H8
In Commercial Distribution

  • 04540778177017 ()

  • Complex (Extra Soft) 10inch 3.5mm x 8cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
392-03H8

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176997

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0306
In Commercial Distribution

  • 04540778176997 ()

  • Complex (Extra Soft) 10inch 3mm x 6cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
392-0306

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176980

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0304
In Commercial Distribution

  • 04540778176980 ()

  • Complex (Extra Soft) 10inch 3mm x 4cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
392-0304

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176591

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-0308
In Commercial Distribution

  • 04540778176591 ()

  • Complex (Silky Soft) 10inch 3mm x 8cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0308

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176584

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-0306
In Commercial Distribution

  • 04540778176584 ()

  • Complex (Silky Soft) 10inch 3mm x 6cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0306

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176577

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-0304
In Commercial Distribution

  • 04540778176577 ()

  • Complex (Silky Soft) 10inch 3mm x 4cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0304

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176553

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-02H6
In Commercial Distribution

  • 04540778176553 ()

  • Complex (Silky Soft) 10inch 2.5mm x 6cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-02H6

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176546

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-02H4
In Commercial Distribution

  • 04540778176546 ()

  • Complex (Silky Soft) 10inch 2.5mm x 4cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-02H4

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176539

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-0208
In Commercial Distribution

  • 04540778176539 ()

  • Complex (Silky Soft) 10inch 2mm x 8cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0208

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176522

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-0206
In Commercial Distribution

  • 04540778176522 ()

  • Complex (Silky Soft) 10inch 2mm x 6cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0206

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176515

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-0204
In Commercial Distribution

  • 04540778176515 ()

  • Complex (Silky Soft) 10inch 2mm x 4cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0204

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176508

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-0203
In Commercial Distribution

  • 04540778176508 ()

  • Complex (Silky Soft) 10inch 2mm x 3cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0203

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176485

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-01H4
In Commercial Distribution

  • 04540778176485 ()

  • Complex (Silky Soft) 10inch 1.5mm x 4cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-01H4

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176478

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-01H3
In Commercial Distribution

  • 04540778176478 ()

  • Complex (Silky Soft) 10inch 1.5mm x 3cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-01H3

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176461

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-01H2
In Commercial Distribution

  • 04540778176461 ()

  • Complex (Silky Soft) 10inch 1.5mm x 2cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-01H2

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176447

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-0103
In Commercial Distribution

  • 04540778176447 ()

  • Complex (Silky Soft) 10inch 1mm x 3cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0103

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176430

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-0102
In Commercial Distribution

  • 04540778176430 ()

  • Complex (Silky Soft) 10inch 1mm x 2cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0102

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

i-ED COIL - 04540778176423

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
390-0101
In Commercial Distribution

  • 04540778176423 ()

  • Complex (Silky Soft) 10inch 1mm x 1cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0101

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

TIMER SWITCH - 00606509900133

A device used for controlling connected electrical devices that are programmed to function/operate at or between set intervals of time.
Pride Mobility Products Corp
TIMER SWITCH
In Commercial Distribution

  • 00606509900133 ()
N/A

  • Timer switch

Multimeter MagicMaX-Universal - EIBAVD02020100

Multimeter MagicMaX developed in accordance with IEC 61674. Flexible solution for exact dose- and kV-measurements at all X-ray units incl. CT.
IBA Dosimetry GmbH
VD0202010
In Commercial Distribution

  • EIBAVD02020100 ()
VD0202010

  • Diagnostic x-ray system quality assurance device

Novo Surgical Inc. - 00842331158506

schuknecht roller knife, curved shaft, 7 1/2" (19.0 cm), 3.0 mm diameter roller blade at 90 degree angle to shaft
NOVO SURGICAL, INC.
E7215-82
In Commercial Distribution

  • 00842331158506 ()
E7215-82

  • Skin grafting knife

Novo Surgical Inc. - 00842331143618

nagahara nucleus chopper, 1.25 mm tip & blade offset at 60 degree angle, round knurled handle, 4 1/2" (11.4 cm), left
NOVO SURGICAL, INC.
OP7122-25
In Commercial Distribution

  • 00842331143618 ()
OP7122-25

  • Eye muscle hook, reusable

MSI Precision Specialty Instruments - 00194613085179

Nagahara Ambidextrous Nucleus Chopper, Round Knurled Handle, 1.5mm Tip, Blade Set At 90 Degrees Angle, Overall Length 4 1/2" (11cm)
Med Saver, Inc.
15-3626AS
In Commercial Distribution

  • 00194613085179 ()


  • Ophthalmic knife, reusable

Power Dental USA - D94381007

PIEZO BONE SURGERY TIPS FOR SURGIMASTER AND SURGIMASTER II,DUS5 SHARP AT THREE SIDES HARVESTER TO HARVEST AUTOGENOUS BONE BLOCKS, RIDGE.
Power Dental U.S.A. Inc.
8100-7
In Commercial Distribution

  • D94381007 ()
8100-7

  • Dressing/utility forceps, scissors-like, reusable
  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal

ComPel Isolation Gown - 00634916792713

ComPel Isolation Gown, 3 Armhole, AAMI Level 2, XL, Wrap Around, Velcro at Shoulder, Bound All Around, Long Sleeves with Cuffs
STANDARD TEXTILE CO., INC.
661Y4804
In Commercial Distribution

  • 00634916792713 ()


  • Isolation gown, reusable

AlcoMate - 00853464001119

The 2nd Generation Re-Inforced Semiconductor Sensor by AlcoMate. Replacement needed every 200 tests or at least once yearly, whichever comes first.
AK Globaltech Corp
SM7000
In Commercial Distribution

  • 00853464001119 ()
AKG SM7000

  • Alcohol breath analyser

CORTAC® - 00650551087410

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-066-NS
In Commercial Distribution

  • 00650551087410 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-066-NS

  • Cortical electrode

CORTAC® - 00650551087403

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-066-NS
In Commercial Distribution

  • 00650551087403 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111-16-066-NS

  • Cortical electrode

CORTAC® - 00650551087335

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-062-NS
In Commercial Distribution

  • 00650551087335 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111TX-16-062-NS

  • Cortical electrode

CORTAC® - 00650551087328

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-062-NS
In Commercial Distribution

  • 00650551087328 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111-16-062-NS

  • Cortical electrode

CORTAC® - 00650551074670

SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 1X8, RADIOPAQUE "L" AT CONTACT #1 & #8, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-08-093-NS
In Commercial Distribution

  • 00650551074670 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.76 Millimeter
2110-08-093-NS

  • Cortical electrode

Transport shelf - 00670482000722

The transport shelf is an accessory. It's intended to be installed at foot end of the bed in the corner bumper.
Umano Medical Inc
299-0523WG-TRI
In Commercial Distribution

  • 00670482000722 ()
  • 10670482000729 ()


  • Basic electric hospital bed
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