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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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PCRopsis - B550227610000

PCRopsis™ BCS Nano (1000 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B550227610000 ()
22761000

  • Red blood cell separation reagent

Integra Peritoneal Open-Ended Catheter With Slits - 10381780072546

Integra Peritoneal Open-Ended Catheter With Slits PERITONEAL CATHETER, 90CM LENGTH 12 mm H2O at a flow rate of 23 ml/hr.
Integra Lifesciences Corporation
NL98003S01
In Commercial Distribution

  • 10381780072546 ()
  • M269NL98003S011 ()

  • Tubing: 1.3mm ID x 2.5mm OD; Total Length: 90 cm (35 1/2") (All dimensions nominal)
NL98003S01

  • Peritoneal/atrial cerebrospinal fluid catheter

i-ED COIL - 04540778177031

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
392-0408
In Commercial Distribution

  • 04540778177031 ()

  • Complex (Soft) 10inch 4mm x 8cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
392-0408

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil

Arthrex® - 00888867286580

Thrombinator™ System
ARTHREX, INC.
ABS-10080
In Commercial Distribution

  • 00888867286580 ()
ABS-10080

  • Haematological concentrate system preparation kit, thrombin separation

Medichoice - 10885632101403

Speculum Vaginal Medium Disposable Clear Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
VAG1002
In Commercial Distribution

  • 30885632101407 ()
  • 10885632101403 ()
  • 50885632101401 ()


  • Vaginal speculum, reusable

Medichoice - 10885632101397

Speculum Vaginal Small Disposable Clear Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
VAG1001
In Commercial Distribution

  • 30885632101391 ()
  • 10885632101397 ()
  • 50885632101395 ()


  • Vaginal speculum, reusable

CORTAC® - 00650551052838

SUBDURAL GRID ELECTRODE, PLATINUM, 20 CONTACT, 4X5, SMOOTH, INLINE CONNECTOR, 2 EXITS, 2 LEADS, 2 TAILS, #1 CONTACT AT RIGHT CORNER NUMBERED
PMT CORPORATION
2110-20-046
In Commercial Distribution

  • 00650551052838 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2110-20-046

  • Cortical electrode

CORTAC® - 00650551060932

SUBDURAL STRIP ELECTRODE, STAINLESS STEEL, 8 CONTACT, 1X8, RADIOPAQUE "L" AT CONTACT #1 & #8, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-08-093
In Commercial Distribution

  • 00650551060932 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 3 Millimeter
2111-08-093

  • Cortical electrode

Ventricular Catheter - 10381780033332

20 cm Radiopaque Straight Ventricular Catheter with large holes and graphite based length marks at 5, 10, 15 cm from the tip.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
901302
Not in Commercial Distribution

  • 10381780033332 ()
  • M2729013021 ()

  • Vent. Cath. 20cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Introducer 22cm Length
901302

  • Intracerebral infusion/drainage catheter, short-term

ACTEON - 03609820877044

Circular scalpel angled at 130°, for osteoplasty, harvesting of bone particles or chips. Ridge osteoplasty, periodontal surgery, cysts exerisis, Alternative DI : 10887587009728
SATELEC
03.000.405S
In Commercial Distribution

  • 03609820877044 ()
F87704

  • Hard/soft-tissue ultrasonic surgical system
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