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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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MENTOR Diaphragm Valve Fill Tube LONG 61cm 24in with 45 Degree Connector - 00081317009054

DV Fill Tube
MENTOR TEXAS L.P.
600975-004
In Commercial Distribution

  • 00081317009054 ()
600975-004

  • Saline-filled breast implant, unstructured, smooth-surface

Cochlear™ Nucleus® CI612 cochlear implant with Contour Advance® electrode - 09321502036818

N/A
COCHLEAR LIMITED
P774600
In Commercial Distribution

  • 09321502036818 ()
P774600

  • Cochlear implant system electrode array assembly

THORATEC® PVAD™, ATRIAL CANNULA - SHORT, BEVELED TIP WITH SIDE HOLES - 00813024012115

No Description
Thoratec Corporation
10075-2574-001
In Commercial Distribution

  • 00813024012115 ()
10075-2574-001

  • External ventricular circulatory assist system

THORATEC® PVAD™, ATRIAL CANNULA - LONG, BEVELED TIP WITH SIDE HOLES - 00813024012108

No Description
Thoratec Corporation
10075-2573-001
In Commercial Distribution

  • 00813024012108 ()
10075-2573-001

  • External ventricular circulatory assist system

Cochlear™ Nucleus® Nexa™ cochlear implant with Slim 20 electrode - 09321502053105

Cochlear Implant
COCHLEAR LIMITED
CI1024
In Commercial Distribution

  • 09321502053105 ()
P1549674

  • Cochlear implant system electrode array assembly

Cochlear™ Nucleus® Nexa™ cochlear implant with Slim Modiolar electrode - 09321502053099

Cochlear Implant
COCHLEAR LIMITED
CI1032
In Commercial Distribution

  • 09321502053099 ()
P1434929

  • Cochlear implant system electrode array assembly

Cochlear™ Nucleus® Nexa™ cochlear implant with Slim Straight electrode - 09321502053082

Cochlear Implant
COCHLEAR LIMITED
CI1022
In Commercial Distribution

  • 09321502053082 ()
Z334204

  • Cochlear implant system electrode array assembly

INTERA - 00850014110055

Special Bolus Needle for use with Intera 3000 Hepatic Artery Infusion Pump Straight Length 2" (5 cm)
Intera Oncology Inc.
AP-04032-5
In Commercial Distribution

  • 10850014110052 ()
  • 00850014110055 ()

  • Needle Gauge: 20 Gauge
  • Length: 2 Inch
AP040325

  • Hypodermic needle, single-use

INTERA - 00850014110024

Non-coring (Huber) needle for use with Intera 3000 Hepatic Artery Infusion Pump, Straight, 22 Gauge, 1.5 inch
Intera Oncology Inc.
AP-04011
In Commercial Distribution

  • 10850014110021 ()
  • 00850014110024 ()

  • Length: 1.5 Inch
  • Needle Gauge: 22 Gauge
AP04011

  • Hypodermic needle, single-use

ASPIRE Cristalle Digital Breast Tomosynthesis Option - 04547410351316

The Fujifilm ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) Option acquires and generates FFDM and DBT images.
FUJIFILM CORPORATION
DR 3500 TOMO KIT V2.0 USA E
In Commercial Distribution

  • 04547410351316 ()


  • Stationary mammographic x-ray system, digital
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