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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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SUBDURAL GRID ELECTRODE, PLATINUM, 64 CONTACT, 8X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 4 EXITS, 4 LEADS, 4 TAILS, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-64-061
In Commercial Distribution

  • 00650551056294 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2110-64-061

  • Cortical electrode
SUBDURAL GRID ELECTRODE, PLATINUM, 64 CONTACT, 8X8, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 4 EXITS, 4 LEADS, 4 TAILS, ALL CONTACTS NUMBERED
PMT CORPORATION
2110TX-64-061-NS
In Commercial Distribution

  • 00650551080879 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2110TX-64-061-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, PLATINUM, 64 CONTACT, 8X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 4 EXITS, 4 LEADS, 4 TAILS, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-64-061-NS
In Commercial Distribution

  • 00650551080862 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2110-64-061-NS

  • Cortical electrode
Akahoshi-Tjia MICS Capsularhexis Forceps Round Handle, Special Alignment Mechanism for Incisions as Small as 1.8mm. Triangular Tips, Laser Lines at 1mm Increments, Vaulted Shafts
Med Saver, Inc.
15-5455-VR
In Commercial Distribution

  • 00194613119270 ()


  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Cogswell Surgical Aspirator #3, one-piece, 9.6" long, 2.3mm dia opening, 1-piece suction tube finger hole located at the concave area midway along the tube
Avalign Technologies, Inc.
72-3610310
In Commercial Distribution

  • 00190776387488 ()


  • ENT surgical procedure kit, non-medicated, reusable
GOWN, ISOLATION LEVEL 1, BLUE, UNIVERSAL SIZE, HOOK & LOOP NECK, FULL BACK W/TIE AT WAIST, ELASTIC SLEEVE, 5EA/PK, 20PK/CS (100EA/CS)
Asp Global, LLC
HH-2020-060-1
In Commercial Distribution

  • 00840216123014 ()


  • Isolation gown, single-use
Saunders-Paparella window rasp and marker, 6 1/2'', malleable, straight shaft, straight, mushroom shaped rasp, with markings at 4.0mm, 4.5mm and 5.0mm, hexagonal handle
AMBLER SURGICAL CORP.
Saunders-Paparella window rasp and marker
In Commercial Distribution

  • 00190660130664 ()
69-950

  • Bone file/rasp, manual, reusable
Harms-Colibri Forceps Very Delicate 1x2 Teeth set at 45 Degree, .12mm, with 6mm tying platform, oval hole flat handle, 75mm overall length, stainless steel
Hayden Medical, Inc.
E5-6170
In Commercial Distribution

  • 00840319715604 ()
E5-6170

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
T-Shape, Swivel Oxygen Port; Adult : Tidal Volume Range(75-1500mL), Media(Corrugated Paper), Dead Space(15mL), Breathing Resistance(0.15cm H2O at 30L/min), Weight(7.8g)
Dynarex Corporation
30303
In Commercial Distribution

  • 00840117318106 ()
  • 00840117318113 ()


  • Heat/moisture exchanger, single-use
Adult, Tidal Volume Range (150-1000 mL) Media (Foam + Flat Media), Dead Space (105 (70) mL), Breathing Resistance (1.9cm H2O at 60L / min), Weight (33g)
Dynarex Corporation
30101
In Commercial Distribution

  • 00840117305281 ()
  • 00840117305274 ()


  • Heat/moisture exchanger/microbial medical gas filter
Kelman-McPherson suturing forceps, 4 1/8'', angled 45 degrees shafts, 0.12mm 1x2 teeth set at 90 degrees, 8.0mm tying platforms, ergonomic fenestrated round handle
AMBLER SURGICAL CORP.
Kelman-McPherson suturing forceps
In Commercial Distribution

  • 00190660058890 ()
2358E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
The device is an accessory intended to fill up to six needles or fillers with acrylic resins for vertebroplasty/kyphoplasty at the same time.
TECRES SPA
ASC0000
In Commercial Distribution

  • 08031497001456 ()


  • Orthopaedic cement preparation/delivery kit
Elvarex Forte 3/Leg Extension from below knee to thigh/Knee Comfort/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
77436-00022-00
In Commercial Distribution

  • 04019702258455 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
The WristAssist Model 4300M is a wrist support device that extends the patient's wrist at a consistent 30° angle The pad is extra large.
Semler Technologies, Inc.
4300M
In Commercial Distribution

  • 20815614020344 ()
  • 10815614020347 ()
140-0300-00-M

  • Wrist immobilizer, single-use
Elvarex Forte 3/Thigh High/Profile, Slant, Open Toe, E-Version, Knee Comfort/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
77428-00804-00
In Commercial Distribution

  • 04019702546651 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
The device includes a Ho:Yag laser source with 35W max output power at 2100 nm wavelength. The optical delivery system is an optical fiber.
Asclepion Laser Technologies GmbH
J19-1310-000
In Commercial Distribution

  • 04058784001092 ()


  • General/multiple surgical solid-state laser system
LIFE®SoftPac replacement/spare cylinder. Includes cylinder, valve, gauge, and 255 liters of oxygen. Provides 40 minute supply of oxygen at 6 LPM.
Mv Life LLC
LIFE-2-101
In Commercial Distribution

  • B188LIFE21010 ()

  • Total Volume: 255 Liter


  • Oxygen refillable cylinder
LIFE®OxygenPac replacement/spare cylinder. Includes cylinder, valve, gauge, and 566 liters of oxygen. Provides 90 minute supply of oxygen at 6 LPM.
Mv Life LLC
LIFE-101
In Commercial Distribution

  • B188LIFE1010 ()

  • Total Volume: 566 Liter


  • Oxygen refillable cylinder
LIFE®OxygenPac is an easily portable, wall-mounted Emergency Oxygen Unit. A 0-25LPM, variable-flow regulator provides a 90 minute supply of oxygen at 6LPM.
Mv Life LLC
LIFE-025
In Commercial Distribution

  • B188LIFE0250 ()

  • Total Volume: 566 Liter


  • Fixed-regulator oxygen refillable cylinder
Azur Nitrile Powder-Free, X-Large, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061705
In Commercial Distribution

  • D79010617053 ()
  • D79010617051 ()
  • D79010617050 ()
1061705

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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