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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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Accu-Beam - B17731250

Fixed focus lens assembly for single puncture set, f400mm.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
3125
In Commercial Distribution

  • B17731250 ()


  • Laparoscope laser coupler

Accu-Beam - B17731160

Zoom Focusing system, f180mm-400mm.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
3116
In Commercial Distribution

  • B17731160 ()


  • Laparoscope laser coupler

Oxygen Kit - 00848530105792

Atrium Health At Home O2 Kit This kit contains: (2) RES001, (1) RES012, (2) RES018, (6) RES1107S, (2) RES3040G, (1) RES003, (1) RES050, (1) HUM008S-1, (1) RES019
SUNSET HEALTHCARE SOLUTIONS, INC.
ATRIUMHAHO2KIT
In Commercial Distribution

  • 00848530105792 ()


  • Oxygen administration kit

Isolation Gown EasyRelease - 00634916790528

Isolation Gown EasyRelease, AAMI Level 1, generic polyester, Yellow, XL, Velcro Hook & Loop Closures at Neck/Waist, Long Sleeves with Natural White Non-Linting Cuffs and Cuff Shields
STANDARD TEXTILE CO., INC.
661Y2632
Not in Commercial Distribution

  • 00634916790528 ()


  • Isolation gown, reusable

Isolation Gown EasyRelease - 00634916790511

Isolation Gown EasyRelease, AAMI Level 1, generic polyester, Yellow, Large, Velcro Hook & Loop Closures at Neck/Waist, Long Sleeves with Natural White Non-Linting Cuffs and Cuff Shields
STANDARD TEXTILE CO., INC.
661Y2635
In Commercial Distribution

  • 00634916790511 ()


  • Isolation gown, reusable

RXEars - 00851362008438

Hearing Device incorporating an adjustable rocker volume control and memory control to fit mild to moderate HL. May also be programmed at the factory for small variations.
Persona Medical
RX4
In Commercial Distribution

  • 00851362008438 ()


  • Air-conduction hearing aid, behind-the-ear

RXEars - 00851362008322

Hearing Device incorporating an adjustable push-button volume control and memory control to fit mild to moderate HL. May also be programmed at the factory for small variations.
Persona Medical
RXS
In Commercial Distribution

  • 00851362008322 ()


  • Air-conduction hearing aid, behind-the-ear

CORTAC® - 00650551051169

SUBDURAL GRID ELECTRODE, PLATINUM, 12 CONTACT, 2X3, DOUBLE SIDED, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 2 EXITS, 2 LEADS, 2 TAILS, TOP & BOTTOM ROWS NUMBERED
PMT CORPORATION
2110TX-12-069
In Commercial Distribution

  • 00650551051169 ()

  • Thickness 1.01 Millimeter
  • Contact Diameter 3 Millimeter
2110TX-12-069

  • Cortical electrode

CORTAC® - 00650551050919

SUBDURAL STRIP ELECTRODE, PLATINUM, 12 CONTACT, 1X6, DOUBLE SIDED, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, 2 LEADS, 2 TAILS, TOP & BOTTOM ROWS NUMBERED
PMT CORPORATION
2110TX-12-003
In Commercial Distribution

  • 00650551050919 ()

  • Contact Diameter 3 Millimeter
  • Thickness 1.01 Millimeter
2110TX-12-003

  • Cortical electrode

CORTAC® - 00650551050902

SUBDURAL STRIP ELECTRODE, PLATINUM, 12 CONTACT, 1X6, DOUBLE SIDED, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, 2 LEADS, 2 TAILS, TOP & BOTTOM ROWS NUMBERED
PMT CORPORATION
2110-12-003
In Commercial Distribution

  • 00650551050902 ()

  • Contact Diameter 3 Millimeter
  • Thickness 1.01 Millimeter
2110-12-003

  • Cortical electrode
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