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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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The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaque polyurethane catheter which contains a Dacron biomaterial cuff and two female luer connectors. The DISC (Dermal Ingrowth Support Collar) assists with the direction of the catheter and consists of a biomaterial tissue ingrowth scaffold. The biomaterial scaffolds on the catheter shaft and DISC are aligned and facilitate tissue ingrowth, which is considered important in reducing the source of extraluminal infection in patients requiring long term catheterisation. The Catheter, DISC and the following ancillary components required for the procedure (0.038” guidewire, Stainless Steel Tunneler and Sleeve, 16Fr Introducer / Dilatorl and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a sterile pouch so that the tray can be delivered to the sterile field
MARVAO MEDICAL DEVICES LIMITED
NEXHD1554002
In Commercial Distribution

  • 05391525640327 ()
  • 05391525640334 ()

  • Length: 40 Centimeter
NEXHD1554002

  • Double-lumen haemodialysis catheter, implantable
The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaque polyurethane catheter which contains a Dacron biomaterial cuff and two female luer connectors. The DISC (Dermal Ingrowth Support Collar) assists with the direction of the catheter and consists of a biomaterial tissue ingrowth scaffold. The biomaterial scaffolds on the catheter shaft and DISC are aligned and facilitate tissue ingrowth, which is considered important in reducing the source of extraluminal infection in patients requiring long term catheterisation. The Catheter, DISC and the following ancillary components required for the procedure (0.038” guidewire, Stainless Steel Tunneler and Sleeve, 16Fr Introducer / Dilator and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a sterile pouch so that the tray can be delivered to the sterile field
MARVAO MEDICAL DEVICES LIMITED
NEXHD1553602
In Commercial Distribution

  • 05391525640303 ()
  • 05391525640310 ()

  • Length: 36 Centimeter
NEXHD1553602

  • Double-lumen haemodialysis catheter, implantable
The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaque polyurethane catheter which contains a Dacron biomaterial cuff and two female luer connectors. The DISC (Dermal Ingrowth Support Collar) assists with the direction of the catheter and consists of a biomaterial tissue ingrowth scaffold. The biomaterial scaffolds on the catheter shaft and DISC are aligned and facilitate tissue ingrowth, which is considered important in reducing the source of extraluminal infection in patients requiring long term catheterisation. The Catheter, DISC and the following ancillary components required for the procedure (0.038” guidewire, Stainless Steel Tunneler and Sleeve, 16Fr Introducer / Dilator and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a sterile pouch so that the tray can be delivered to the sterile field
MARVAO MEDICAL DEVICES LIMITED
NEXHD1553202
In Commercial Distribution

  • 05391525640280 ()
  • 05391525640297 ()

  • Length: 32 Centimeter
NEXHD1553202

  • Double-lumen haemodialysis catheter, implantable
The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaque polyurethane catheter which contains a Dacron biomaterial cuff and two female luer connectors. The DISC (Dermal Ingrowth Support Collar) assists with the direction of the catheter and consists of a biomaterial tissue ingrowth scaffold. The biomaterial scaffolds on the catheter shaft and DISC are aligned and facilitate tissue ingrowth, which is considered important in reducing the source of extraluminal infection in patients requiring long term catheterisation. The Catheter, DISC and the following ancillary components required for the procedure (0.038” guidewire, Stainless Steel Tunneler and Sleeve, 16Fr Introducer / Dilator and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a sterile pouch so that the tray can be delivered to the sterile field
MARVAO MEDICAL DEVICES LIMITED
NEXHD1552802
In Commercial Distribution

  • 05391525640266 ()
  • 05391525640273 ()

  • Length: 28 Centimeter
NEXHD1552802

  • Double-lumen haemodialysis catheter, implantable
The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaque polyurethane catheter which contains a Dacron biomaterial cuff and two female luer connectors. The DISC (Dermal Ingrowth Support Collar) assists with the direction of the catheter and consists of a biomaterial tissue ingrowth scaffold. The biomaterial scaffolds on the catheter shaft and DISC are aligned and facilitate tissue ingrowth, which is considered important in reducing the source of extraluminal infection in patients requiring long term catheterisation. The Catheter, DISC and the following ancillary components required for the procedure (0.038” guidewire, Stainless Steel Tunneler and Sleeve, 16Fr Introducer / Dilator and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a sterile pouch so that the tray can be delivered to the sterile field
MARVAO MEDICAL DEVICES LIMITED
NEXHD1552402
In Commercial Distribution

  • 05391525640242 ()
  • 05391525640259 ()

  • Length: 24 Centimeter
NEXHD1552402

  • Double-lumen haemodialysis catheter, implantable
The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaque polyurethane catheter which contains a Dacron biomaterial cuff and two female luer connectors. The DISC (Dermal Ingrowth Support Collar) assists with the direction of the catheter and consists of a biomaterial tissue ingrowth scaffold. The biomaterial scaffolds on the catheter shaft and DISC are aligned and facilitate tissue ingrowth, which is considered important in reducing the source of extraluminal infection in patients requiring long term catheterisation. The Catheter, DISC and the following ancillary components required for the procedure (0.038” guidewire, Stainless Steel Tunneler and Sleeve, 16Fr Introducer / Dilator and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a sterile pouch so that the tray can be delivered to the sterile field
MARVAO MEDICAL DEVICES LIMITED
NEXHD1555502
In Commercial Distribution

  • 05391525640341 ()
  • 05391525640358 ()

  • Length: 55 Centimeter
NEXHD1555502

  • Double-lumen haemodialysis catheter, implantable
The FTRD System Set is a novel tool for diagnostic and therapeutic full-thickness resection via flexible endoscope in colon and rectum • technology is based on OTSC System • enabling the endoscopist to resect all layers of suitable lesions including the serosa • transection of the tissue happens after the defect has been closed completely • bowel lumen and abdominal cavity won't get into contact • it consists of the following instruments: FTRD System (application cap with preloaded clip and integrated HF snare) • FTRD Marking Probe (HF coagulation probe | marking of the target lesion in preparation of FTRD System use | for detection and complete resection of the right tissue) • FTRD Grasper (specially designed grasping forceps | proper grip on the target tissue | precise retrieval of the sample into the application cap of the FTRD System)
Ovesco Endoscopy AG
14
Not in Commercial Distribution

  • 04260206310556 ()

  • working length 220 cm
  • working channel diameter 2.8 mm
  • for endoscopes diameter 11.5-13.2 mm
200.70

  • Endoscopic electrosurgical full-thickness tissue biopsy/resection set
B-GENIN is a bone void filler consisting of purified bovine collagen and demineralized bone matrix (DBM). The collagen component is biocompatible. After it is implanted, it resorbs and is later replaced by natural bone. B-GENIN is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed blood prior to use at the physician's discretion.
BERKELEY ADVANCED BIOMATERIALS, LLC
BGT-100x25-10
In Commercial Distribution

  • 00816125022007 ()
BGT-100x25-10

  • Cadaveric-donor/synthetic mineral bone graft
B-GENIN is a bone void filler consisting of purified bovine collagen and demineralized bone matrix (DBM). The collagen component is biocompatible. After it is implanted, it resorbs and is later replaced by natural bone. B-GENIN is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed blood prior to use at the physician's discretion.
BERKELEY ADVANCED BIOMATERIALS, LLC
BG1-100X25-10
In Commercial Distribution

  • 00816125021994 ()
BG1-100X25-10

  • Cadaveric-donor/synthetic mineral bone graft
B-GENIN is a bone void filler consisting of purified bovine collagen and demineralized bone matrix (DBM). The collagen component is biocompatible. After it is implanted, it resorbs and is later replaced by natural bone. B-GENIN is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed blood prior to use at the physician's discretion.
BERKELEY ADVANCED BIOMATERIALS, LLC
BG2-100X25-10
In Commercial Distribution

  • 00816125021987 ()
BG2-100X25-10

  • Cadaveric-donor/synthetic mineral bone graft
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