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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Compact PERINE Probe. Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology application. Frequencies: 4-9 MHz Field of view 72 mm Scanning angle 170°
KOELIS
K3DEL00-2
In Commercial Distribution

  • 03665134000851 ()
  • 03665134000844 ()
K3DEL00-2

  • General-purpose ultrasound imaging system
Surface 2D probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, small organs, soft tissues, urology and vascular applications Frequencies: 7-15MHz Field of view 40 mm
KOELIS
K2DLN00
In Commercial Distribution

  • 03665134000530 ()
  • 03665134000103 ()


  • General-purpose ultrasound imaging system
Surface 2D probe (Convex) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, soft tissues, Urology and Vascular applications Frequencies: 2-5MHz Field of view 460° Radius 60 mm
KOELIS
K2DAB00
In Commercial Distribution

  • 03665134000523 ()
  • 03665134000097 ()


  • General-purpose ultrasound imaging system
Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology application. Frequencies: 4-9 MHz Field of view 72 mm Scanning angle 170°
KOELIS
K3DEL00
In Commercial Distribution

  • 03665134000516 ()
  • 03665134000080 ()


  • General-purpose ultrasound imaging system
Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology and gynecology applications. Frequencies: 4-9 MHz Field of view 146° Scanning angle 90° Radius 10 mm
KOELIS
K3DEC00-2
In Commercial Distribution

  • 03665134000509 ()
  • 03665134000073 ()


  • General-purpose ultrasound imaging system
DIACAP ULTRA DF FILTER CA & US
B.Braun Avitum AG
7107368
In Commercial Distribution

  • 04046963178109 ()
  • 04046963178116 ()
7107368

  • Haemodialysis system dialysate pyrogen filter
No Description
Stockert GmbH
20403
In Commercial Distribution

  • 04260166374094 ()
M004GEN100204030

  • Cardiac radio-frequency ablation system generator
No Description
Stockert GmbH
20402
In Commercial Distribution

  • 04260166374087 ()
M004GEN100204020

  • Bedside infusion pump, single-channel
No Description
Stockert GmbH
20401
In Commercial Distribution

  • 04260166374070 ()
M004GEN100204010

  • Cardiac radio-frequency ablation system generator
No Description
Stockert GmbH
20010
In Commercial Distribution

  • 04260166373066 ()
M004GEN100200100

  • Foot-switch, electrical
CANNULA 77424 EOPA BLUNT 24FR 10PK 11L
MEDTRONIC, INC.
77424
In Commercial Distribution

  • 00763000946791 ()
  • 20763000946795 ()

  • Catheter Gauge: 24.0 French


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
No Description
MEDEX
QIT013
In Commercial Distribution

  • 13700550400971 ()
  • 23700550400978 ()
  • 33700550400975 ()


  • General-purpose syringe, single-use
Qitexio(R) 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. Qitexio 4-Way Stopcock is not intended to facilitate bi-directional flows, thus is not designed to be used in infusion. Qitexio 4-Way Stopcock is designated for single use only (disposable) and is MR safe. Qitexio 4-Way Stopcock is robust under medium pressure and is verified to be used for Lipiodol (Ethiodized oil) delivery.
MEDEX
QIT014
In Commercial Distribution

  • 33700550400760 ()
  • 23700550400763 ()
  • 13700550400766 ()


  • Stopcock
3 ml Luer Lock Syringe
MEDEX
QIT012
In Commercial Distribution

  • 33700550400746 ()
  • 23700550400749 ()
  • 13700550400742 ()


  • General-purpose syringe, single-use
1 ml Luer Lock Syringe
MEDEX
QIT011
In Commercial Distribution

  • 33700550400739 ()
  • 23700550400732 ()
  • 13700550400735 ()


  • General-purpose syringe, single-use
Resectoscopic System, Outer Sheath, Rotatable, 27 Fr.
Ethicon Inc.
01939
Not in Commercial Distribution

  • 10705031000964 ()
01939

  • Endoscope sheath, reusable
Resectoscopic System, Hysteroscope 4.0mm 12°, High Magnification
Ethicon Inc.
01938
Not in Commercial Distribution

  • 10705031000957 ()
01938

  • Rigid optical hysteroscope
Resectoscopic System, Hysteroscope 4.0mm 30°, Wide Angle
Ethicon Inc.
01936
Not in Commercial Distribution

  • 10705031000940 ()
01936

  • Rigid optical hysteroscope
Resectoscopic System, Obturator, Standard
Ethicon Inc.
01934
Not in Commercial Distribution

  • 10705031000933 ()
01934

  • Rigid endoscope obturator
Resectoscopic System, Working Element, Passive
Ethicon Inc.
01931
Not in Commercial Distribution

  • 10705031000926 ()
01931

  • Electrosurgical handpiece/electrode holder, reusable
Resectoscopic System, Bridge - Hysteroscopic (Obturator - Visual)
Ethicon Inc.
01735
Not in Commercial Distribution

  • 10705031000919 ()
01735

  • Rigid endoscope obturator
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
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
NEXHDSY1555501
In Commercial Distribution

  • 05391525640501 ()
  • 05391525640518 ()

  • Length: 55 Centimeter
NEXHDSY1555501

  • 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
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
NEXHDSY1553101
In Commercial Distribution

  • 05391525640464 ()
  • 05391525640471 ()

  • Length: 31 Centimeter
NEXHDSY1553101

  • 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
NEXHDSY1552701
In Commercial Distribution

  • 05391525640457 ()
  • 05391525640440 ()

  • Length: 27 Centimeter
NEXHDSY1552701

  • 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
NEXHDSY1552301
In Commercial Distribution

  • 05391525640426 ()
  • 05391525640433 ()

  • Length: 23 Centimeter
NEXHDSY1552301

  • 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
NEXHDSY1551901
In Commercial Distribution

  • 05391525640402 ()
  • 05391525640419 ()

  • Length: 19 Centimeter
NEXHDSY1551901

  • 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 / 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 Split Tip Catheter for long term use is a dual lumen, split 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, 17Fr Introducer / Dilator 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
NEXHDSP165501
In Commercial Distribution

  • 05391525640235 ()
  • 05391525640228 ()

  • Length: 55 Centimeter
NEXHDSP165501

  • Double-lumen haemodialysis catheter, implantable
The NexSite™ HD, Hemodialysis Split Tip Catheter for long term use is a dual lumen, split 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, 17Fr Introducer / Dilator 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
NEXHDSP164001
In Commercial Distribution

  • 05391525640211 ()
  • 05391525640204 ()

  • Length: 40 Centimeter
NEXHDSP164001

  • Double-lumen haemodialysis catheter, implantable
The NexSite™ HD, Hemodialysis Split Tip Catheter for long term use is a dual lumen, split 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, 17Fr Introducer / Dilator 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
NEXHDSP163601
In Commercial Distribution

  • 05391525640181 ()
  • 05391525640198 ()

  • Length: 36 Centimeter
NEXHDSP163601

  • Double-lumen haemodialysis catheter, implantable
The NexSite™ HD, Hemodialysis Split Tip Catheter for long term use is a dual lumen, split 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, 17Fr Introducer / Dilator 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
NEXHDSP163201
In Commercial Distribution

  • 05391525640174 ()
  • 05391525640167 ()

  • Length: 32 Centimeter
NEXHDSP163201

  • Double-lumen haemodialysis catheter, implantable
The NexSite™ HD, Hemodialysis Split Tip Catheter for long term use is a dual lumen, split 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, 17Fr Introducer / Dilator 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
NEXHDSP162801
In Commercial Distribution

  • 05391525640143 ()
  • 05391525640150 ()

  • Length: 28 Centimeter
NEXHDSP162801

  • Double-lumen haemodialysis catheter, implantable
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