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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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AED Battery Exchange - 00864312000253

Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) G3 9300A,, 9300E, 9390A, 9390E and Burdick Cardiovive AT (TM). Color White.
AED BATTERY EXCHANGE, LLC
9146-W-ABE
In Commercial Distribution

  • 00864312000253 ()


  • Primary battery

AED Battery Exchange - 00864312000239

Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) G3 9300A, 9300E, 9390A, 9390E, and Burdick Cardiovive AT (TM). Color Yellow.
AED BATTERY EXCHANGE, LLC
9146-Y-ABE
In Commercial Distribution

  • 00864312000239 ()


  • Primary battery

CORTAC® - 00650551051312

SUBDURAL GRID ELECTRODE, PLATINUM, 16 CONTACT TAIL WITH #5 DEAD, 4X4, RADIOPAQUE MARKER AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-15-010
In Commercial Distribution

  • 00650551051312 ()

  • Thickness 1.01 Millimeter
  • Contact Diameter 2 & 3 Millimeter
2110-15-010

  • Cortical electrode

CORTAC® - 00650551056300

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
In Commercial Distribution

  • 00650551056300 ()

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

  • Cortical electrode

CORTAC® - 00650551056294

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

ASP MEDICAL - 00840216123014

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

Mendec V FILL - 08031497001456

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

DIASOL - B467CC51

Dialysate Additive 5.1 grams Calcium Chloride to increase Calcium by 0.5 mEq/L when added to 3.785 liters of concentrate proportioned at 1:35.83
DIASOL, INC.
CC5.1
In Commercial Distribution

  • B467CC51220 ()
  • B467CC51 ()

  • Weight: 5.1 Gram
CC2

  • Haemodialysis concentrate

DIASOL - B467CC157

Dialysate Additive 15.7 grams Calcium Chloride to increase Calcium by 0.5 mEq/L when added to 9.46 liters of concentrate proportioned at 1:44
DIASOL, INC.
CC15.7
In Commercial Distribution

  • B467CC157145 ()
  • B467CC157 ()

  • Weight: 15.7 Gram
CC10

  • Haemodialysis concentrate

DIASOL - B467PC104

Dialysate Additive 10.4 grams Potassium Chloride to increase Potassium by 1.0 mEq/L when added to 3.785 liters of concentrate proportioned at 1:35.83
DIASOL, INC.
PC10.4
In Commercial Distribution

  • B467PC104145 ()
  • B467PC104 ()

  • Weight: 10.4 Gram
PC12

  • Haemodialysis concentrate
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