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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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Ambler Surgical - 00190660130664

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

Resp-O2 Heat Moisture Exchanger (HMEF) 1000 B/V CO2 Flex Tube - 00840117305274

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

Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy - 00840117318113

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

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

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

MR PHACO - G412PH2439T0

Shepard Tying Forceps Angled with 4mm Tying Platform, Angled 4.5mm from bend to tip at 45 Degree, Serrated Flat Handle, 108mm Overall Length, Titanium
Crestpoint Management Limited
PH2439T
In Commercial Distribution

  • G412PH2439T0 ()


  • Ophthalmic surgical device handling forceps, reusable

MR PHACO - G412PH23920

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
Crestpoint Management Limited
PH2392
In Commercial Distribution

  • G412PH23920 ()


  • Ophthalmic surgical device handling forceps, reusable

MR PHACO - G412PH23880

Gills-Colibri Utility Forceps Very Fine Pointed Tips set at 45 Degree, with 6mm Tying Platform, Oval Hole Flat Handle, 75mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH2388
In Commercial Distribution

  • G412PH23880 ()


  • Ophthalmic surgical device handling forceps, reusable

MR PHACO - G412PH23820

Harms-Colibri Forceps Very Delicate 1x2 Teeth set at 45 Degree, .12mm, with 6mm Tying Platform, Three Hole Flat Handle, 106mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH2382
In Commercial Distribution

  • G412PH23820 ()


  • Ophthalmic surgical device handling forceps, reusable
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