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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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Shelco Filtration System - B297APT50611005PRECARB0

Pre-Carbons 1" Shelco Housing Assembly, Holds (5) 20” Filters, 5-Micron, With Bypass Valves
SPECIALITY WATER TECHNOLOGY
A-PT-5061-100-5-PRE-CARB
In Commercial Distribution

  • B297APT50611005PRECARB0 ()


  • Particulate water purification filter

Shelco Filtration System - B297APT506110050

Pre-RO 1" Shelco Housing Assembly, Holds (5) 20” Filters, 1-Micron, With Bypass Valves
SPECIALITY WATER TECHNOLOGY
A-PT-5061-100-5
In Commercial Distribution

  • B297APT506110050 ()


  • Particulate water purification filter

Shelco Filtration System - B297APT50611000

Pre-RO 1" Shelco Housing Assembly, Holds (4) 20” Filters, 1-Micron, With Bypass Valves
SPECIALITY WATER TECHNOLOGY
A-PT-5061-100
In Commercial Distribution

  • B297APT50611000 ()


  • Particulate water purification filter

CARDIOPLEGIA NEEDLE - B099280074930

HEARTLINE CARDIOPLEGIA NEEDLE
SONTEC INSTRUMENTS, INC.
2800-7493
Not in Commercial Distribution

  • B099280074930 ()

  • 3.5mm 12 1/2"


  • Pericardiocentesis needle, reusable

CARDIOPLEGIA NEEDLE - B099280074900

HEARTLINE CARDIOPLEGIA NEEDLE
SONTEC INSTRUMENTS, INC.
2800-7490
Not in Commercial Distribution

  • B099280074900 ()

  • 2mm 12 1/5"


  • Pericardiocentesis needle, reusable

CARDIOPLEGIA NEEDLE - 00192896070226

HEARTLINE CARDIOPLEGIA NEEDLE
SONTEC INSTRUMENTS, INC.
2800-7493
In Commercial Distribution


  • 3.5mm 12 1/2"


  • Pericardiocentesis needle, reusable

CARDIOPLEGIA NEEDLE - 00192896070219

HEARTLINE CARDIOPLEGIA NEEDLE
SONTEC INSTRUMENTS, INC.
2800-7490
In Commercial Distribution


  • 2mm 12 1/5"


  • Pericardiocentesis needle, reusable

EpiAccess Needle - B3000399139500

No Description
EPIEP, INC.
0399-13950
In Commercial Distribution

  • B3000399139500 ()


  • Pericardiocentesis needle, single-use

Luminary Blueberry Polymer - D85110

Tinted Glow Powder
JBC and Company
10
In Commercial Distribution

  • D85110 ()
10

  • Dental appliance fabrication material, resin

Summit Medical - B346R0011

NRHZ: A sterile device designed to be securely attached to the septum end of a vial to create a channel, by spiking through the vial's sealed stopper, to allow access to the contents of the vial. This device is intended to reduce risk of unwanted exposure to the vial's contents (e.g., liquid medication) by providing a sterile pathway between the vial and a recipient receptacle/device for subsequent delivery to a patient. It typically consists of polyvinyl chloride (PVC) screw cap with an internal spike and an external connector. This is a single-use device.
DRAGON HEART MEDICAL, INC.
R001
Not in Commercial Distribution

  • B346R0011 ()
  • B346R00129 ()
10

  • Medical air terminal unit
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