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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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One hemigard hook strap and one hemigard loop piece
Suturegard Medical Inc
HRD002
In Commercial Distribution

  • 10860007834223 ()
  • 00860007834226 ()
HRD002

  • Skin-closing tension device
Patient-Specific Maxillofacial/midface implant-Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543425 ()
BETMCT

  • Custom-made cranial bone prosthesis
Patient-Specific Maxillary Implant - Titanium - high complexity
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543418 ()
BEACMXT

  • Custom-made cranial bone prosthesis
Patient-Specific Mandible Implant - Titanium - high complexity
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543401 ()
BEACMT

  • Custom-made cranial bone prosthesis
PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (1 ml)
3-D MATRIX INC.
651-004
Not in Commercial Distribution

  • 00860007400315 ()
651-004

  • Synthetic peptide haemostatic agent
PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (3 ml)
3-D MATRIX INC.
651-005
In Commercial Distribution

  • 00860007400308 ()
651-005

  • Synthetic peptide haemostatic agent
NeuraMedica Dural Clips are bioabsorbable surgical clips designed to aid in closure of the dura mater in neurosurgical and orthopedic spine procedures. NeuraMedica Dural Clips are 3mm wide by 4.6mm long. They are applied using a reusable stainless steel applier. The NeuraMedica Applier is a separately-supplied reusable instrument.
Neuramedica Inc.
DC-501
In Commercial Distribution

  • 00860007130403 ()


  • Ligation clip, synthetic polymer, bioabsorbable
The EndoGI Specialized S-Path Biliary Delivery System is designed for the deployment of Pigtail Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The EndoGI S-Path Delivery System enables insertion and placement of one stent in the common bile and hepatic ducts with one passage of the delivery system while securing and maintaining access of the guidewire at the targeted deployment site. The EndoGI Specialized S-Path Biliary Delivery System is to be loaded with a compatible pigtail stent prior to use. The system is compatible with a 10Fr (2.4 mm inner diameter and 3.4mm outer diameter) pigtail stent with a length of 7 cm (total length up to 20 cm).
ENDO GI MEDICAL LTD
Delivery System
In Commercial Distribution

  • 00860005738250 ()
  • 10860005738257 ()


  • Polymeric biliary stent, non-bioabsorbable
The EndoGI Specialized S-Path Biliary Delivery System is designed for the deployment of Pigtail Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The EndoGI S-Path Delivery System enables insertion and placement of one stent in the common bile and hepatic ducts with one passage of the delivery system while securing and maintaining access of the guidewire at the targeted deployment site. The EndoGI Specialized S-Path Biliary Delivery System is to be loaded with a compatible pigtail stent prior to use. The system is compatible with a 10Fr (2.4 mm inner diameter and 3.4mm outer diameter) pigtail stent with a length of 7 cm (total length up to 20 cm).
ENDO GI MEDICAL LTD
Delivery System
In Commercial Distribution

  • 00860005738243 ()


  • Polymeric biliary stent, non-bioabsorbable
The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the EndoGI Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The stent, made of a radiopaque polymer consists of a tapered proximal end and is endoscopically visible. The EndoGI S-Path Pre-loaded RX Biliary Stent System is available in 10Fr and is supplied with one 140 mm stent preloaded on the Delivery System. A stent barb cover is provided to facilitate placement of the stent into the endoscope.
ENDO GI MEDICAL LTD
Single-Stent (140mm)
In Commercial Distribution

  • 00860005738236 ()

  • Stent Length: 140 Millimeter


  • Polymeric biliary stent, non-bioabsorbable
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