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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 / Dilator, Coring Scalpel and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a second sterile pouch so that the tray can be delivered to the sterile field
MARVAO MEDICAL DEVICES LIMITED
NEXHD1554001
In Commercial Distribution

  • 05391525640099 ()
  • 05391525640082 ()

  • Length: 40 Centimeter
NEXHD1554001

  • 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, Coring Scalpel and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a second sterile pouch so that the tray can be delivered to the sterile field
MARVAO MEDICAL DEVICES LIMITED
NEXHD1553601
In Commercial Distribution

  • 05391525640075 ()
  • 05391525640068 ()

  • Length: 36 Centimeter
NEXHD1553601

  • 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, Coring Scalpel and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a second sterile pouch so that the tray can be delivered to the sterile field
MARVAO MEDICAL DEVICES LIMITED
NEXHD1553201
In Commercial Distribution

  • 05391525640051 ()
  • 05391525640044 ()

  • Length: 32 Centimeter
NEXHD1553201

  • 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, Coring Scalpel and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a second sterile pouch so that the tray can be delivered to the sterile field
MARVAO MEDICAL DEVICES LIMITED
NEXHD1552801
In Commercial Distribution

  • 05391525640020 ()
  • 05391525640037 ()

  • Length: 28 Centimeter
NEXHD1552801

  • 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, Coring Scalpel and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a second sterile pouch so that the tray can be delivered to the sterile field
MARVAO MEDICAL DEVICES LIMITED
NEXHD1552401
In Commercial Distribution

  • 05391525640006 ()
  • 05391525640013 ()

  • Length: 24 Centimeter
NEXHD1552401

  • Double-lumen haemodialysis catheter, implantable
The NexSite™ HD,Hemodialysis Catheter for long term use is a dual lumen, symmetric 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, Catheter Stylet 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
NEXHDSY1553501
In Commercial Distribution

  • 05391525640488 ()
  • 05391525640495 ()

  • Length: 35 Centimeter
NEXHDSY1553501

  • Double-lumen haemodialysis catheter, implantable
Red Etch 60 ml syringe
ORTHOSOURCE
557-468
In Commercial Distribution

  • D911557468601 ()
  • D9115574680 ()


  • Dental etching solution
Blue Etch 60 ml syringe
ORTHOSOURCE
557-467
In Commercial Distribution

  • D9115574670 ()
  • D911557467601 ()


  • Dental etching solution
Green Etch 60 ml syringe
ORTHOSOURCE
557-466
In Commercial Distribution

  • D911557466601 ()
  • D9115574660 ()


  • Dental etching solution
ATRAMAT PGC25 SURGICAL SUTURE VIOLET USP 3-0 EP 2, 70 CM NEEDLE SG-36 PREMIUM HEAVY TAPER POINT 36 MM 1/2 CIRCLE 36 UNITS
Internacional Farmacéutica, S.A. de C.V.
PGC25
In Commercial Distribution

  • 07500142329760 ()
  • 07500142029769 ()

  • Length: 36 Millimeter
  • USP 3-0 EP 2
SG3603-H

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
ATRAMAT POLYESTER SURGICAL SUTURE GREEN USP 2-0 EP 3, 75 CM DOUBLE NEEDLE S-16 PREMIUM TAPER POINT 16 MM 1/2 CIRCLE KIT WITH PLEDGET WITH 6 POUCHES
Internacional Farmacéutica, S.A. de C.V.
POLYESTER
In Commercial Distribution

  • 07500142905049 ()
  • 07500142005046 ()

  • Length: 16 Millimeter
  • USP 2-0 EP 3
S1652/2-75KP6

  • Polyester suture, non-bioabsorbable, multifilament
CATHETER 227F5 FREEZOR XTRA5 LG 7F
MEDTRONIC, INC.
227F5
In Commercial Distribution

  • 00643169672482 ()

  • catheter curve 60mm
  • Catheter Gauge: 7.0 French
  • Length: 108.0 Centimeter
  • catheter tip length 6mm


  • Cardiac cryosurgical system catheter
CATHETER 227F3 FREEZOR XTRA3 MED7F
MEDTRONIC, INC.
227F3
In Commercial Distribution

  • 00643169672475 ()

  • Length: 108.0 Centimeter
  • catheter tip length 6mm
  • Catheter Gauge: 7.0 French
  • catheter curve 55mm


  • Cardiac cryosurgical system catheter
CATHETER 227F1 FREEZOR XTRA1 SH 7F
MEDTRONIC, INC.
227F1
In Commercial Distribution

  • 00643169672468 ()

  • catheter curve 49mm
  • catheter tip length 6mm
  • Catheter Gauge: 7.0 French
  • Length: 108.0 Centimeter


  • Cardiac cryosurgical system catheter
CABLE 203CXC COAXIAL UMBIL BOX 12 ROHS
MEDTRONIC, INC.
203CXC
In Commercial Distribution

  • 20643169950157 ()
  • 00643169950153 ()


  • Liquid nitrous oxide coaxial tubing
CABLE 203CX COAXIAL UMBILICAL ROHS
MEDTRONIC, INC.
203CX
In Commercial Distribution

  • 00643169950146 ()


  • Liquid nitrous oxide coaxial tubing
SHEATH 990065 FLEXCATH SELECT 10 FR 65CM
MEDTRONIC, INC.
990065
Not in Commercial Distribution

  • 00643169688858 ()

  • Usable length 65 cm
  • Dilator inner diameter 1 mm
  • Sheath inner diameter 10 Fr (3.3 mm)


  • Haemostasis valve
SonoVision Accessory Kit Second Dilator
Tissue Differentiation Intelligence LLC
100034
In Commercial Distribution

  • 00860001239386 ()


  • Interventional radiology percutaneous-access kit, reusable
SonoVision Accessory Kit Initial Dilator
Tissue Differentiation Intelligence LLC
100033
In Commercial Distribution

  • 00860001239379 ()


  • Interventional radiology percutaneous-access kit, reusable
SonoVision Accessory Kit Dilator Guide - Double
Tissue Differentiation Intelligence LLC
100030
In Commercial Distribution

  • 00860001239362 ()


  • Interventional radiology percutaneous-access kit, reusable
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