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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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A-1-Antichymotrypsin is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in bufferpH 7.5,
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB50010 ()
BSB5001

  • Alpha-1-antichymotrypsin IVD, antibody
Tinto Somatostatin antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in Phosphate Buffered Saline, pH 7.6
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB59320 ()
BSB 5932

  • Somatostatin IVD, antibody
Tinto Somatostatin antibody is the purified immunoglobulin fraction of rabbit antiserum,diluted in Phosphate Buffered Saline, pH 7.6
BIO SB, INC.
Prediluted, 3 ml
In Commercial Distribution

  • B502BSB59310 ()
BSB5931

  • Somatostatin IVD, antibody
Microhybrid Compule Kit includes 11 packages of Microhybrid Compule (20 compules 0.25 g each/ package) in the Tray.
COSMEDENT, INC.
606205
In Commercial Distribution

  • D7796062053 ()
606205

  • Dental composite resin
Combined Battery and Electrode Cartridge. Accessory to a therapeutic medical device in the range of Automated External Defibrillators.
HEARTSINE TECHNOLOGIES LTD
Pad-Pak-07
In Commercial Distribution

  • M727PADPAK07 ()
Pad-Pak-07

  • Non-rechargeable public semi-automated external defibrillation electrode, adult
Combined Battery and Electrode Cartridge. Accessory to a therapeutic medical device in the range of Automated External Defibrillators.
HEARTSINE TECHNOLOGIES LTD
Pad-Pak-02
In Commercial Distribution

  • M727PADPAK02 ()
Pad-Pak-02

  • Non-rechargeable public semi-automated external defibrillation electrode, paediatric
Combined Battery and Electrode Cartridge. Accessory to a therapeutic medical device in the range of Automated External Defibrillators.
HEARTSINE TECHNOLOGIES LTD
Pad-Pak-01
In Commercial Distribution

  • M727PADPAK01 ()
Pad-Pak-01

  • Non-rechargeable public semi-automated external defibrillation electrode, adult
The GANDRAS catheter is designed to be used for delivering embolic materials and radiopaque media to selected sites in the vascular system. Diagnostic, embolic, or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.
Vascular Solutions, Inc.
5582
Not in Commercial Distribution

  • M20655820 ()
  • M20655821 ()

  • 6 cm Tip
  • Length: 86 Centimeter
  • Catheter Gauge: 5 French


  • Angiographic catheter, single-use
The GANDRAS catheter is designed to be used for delivering embolic materials and radiopaque media to selected sites in the vascular system. Diagnostic, embolic, or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.
Vascular Solutions, Inc.
5581
Not in Commercial Distribution

  • M20655810 ()
  • M20655811 ()

  • Catheter Gauge: 5 French
  • Length: 84 Centimeter
  • 4 cm Tip


  • Angiographic catheter, single-use
Qty 2-0.75mm x 0.5cm Platinum VISICOILS 20mm spacer 18g x 20cm Needle Stranded 2 - 0.75mm x 0.50cm VISICOIL MR separated by 20mm PGLA spacer (Stranded with PGLA Sleeve) loaded in an 18 gauge pre-waxed brachytherapy needle 20cm in length.
Izi Medical Products, LLC
MRTLS-075-92018
In Commercial Distribution

  • B887MRTLS075920180 ()
MRTLS-075-92018

  • Radiological image marker, implantable
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