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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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Kits Contents : Catheter 4FR OD 1.45mmx60mm; J guidewire OD 0.46mmx350mm, Steel Needle Introducer 22G OD 0.75mmx40mm; Overneedle Introducer 20G OD1.07mmx45mm, Dilator 5FR OD 1.7mm ID 0.66mm & Syringe 5ml.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
681616
In Commercial Distribution

  • 50886333616164 ()
  • 00886333616169 ()

  • Catheter 4FR OD 1.45mmx60mm
681616

  • Vascular catheter introduction set, nonimplantable
Kits Contents : Catheter 2.5FR OD 0.9mmx60mm; J guidewire OD 0.46mmx350mm, Steel Needle Introducer 22G OD 0.75mmx40mm; Overneedle Introducer 22G OD0.82mmx38mm, Dilator 4FR OD 1.27mm ID 0.51mm & Syringe 5ml.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
681612
In Commercial Distribution

  • 50886333616126 ()
  • 00886333616121 ()

  • Catheter 2.5FR OD 0.9mmx60mm
681612

  • Vascular catheter introduction set, nonimplantable
Kits Contents : Percutaneous Sheath Introducer with Sideport Haemostasis Valve OD 3.53mm x ID 2.74mm x 10cm and Dilator, guidewire 0.9x450mm, Introducers 1.7x70mm,1.4x70mm, Contamination Shield, stopcock, syringe, scalpel.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
680124
In Commercial Distribution

  • 50886333601245 ()
  • 00886333601240 ()

  • Catheter 8.5Fr
680124

  • Haemostasis valve
STar(TM) Drive Array Electrode Insertion Tube Set for use with microTargeting(TM) Platform, non-sterile Set Contains: 6x IT(AR18) Guide Tube, 1.83mm OD (does not enter brain) 6x IT(AR19) Insertion Tube with Stylet - 186.7mm length, 0.87mm od, 0.60mm id 1x IT(AR4) DBS Lead Insertion Tube with Stylet - 188.05mm length, 1.83mm od, 1.60mm id. 2x Insertion Tube Extractors
FHC, INC.
70-IT-04-00218
In Commercial Distribution

  • 00873263002186 ()
70-IT-04

  • Intracerebral cannula, nonimplantable, reusable
Integrity software for use with the first generation Integrity V500 system (DI: 00627908010018) and the second generation of the Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
Vivosonic Inc
SWA001
In Commercial Distribution

  • 00627908090010 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
Anesthesia Circuit, adult, 96" expandable parallel WYE w/GSP, GSE, In-Line HMEF, 3L not made with latex breathing bag, GSL, 10' x .50 ID M/F, B/V Filter
WESTMED, INC.
9344
In Commercial Distribution

  • 10709078011211 ()
  • 00709078011214 ()


  • Anaesthesia breathing circuit, single-use
Anesthesia Circuit, Adult, 60" Expandable, parallel WYE, GSL 10' x .050" ID M/M, 3L not made with latex breathing bag, B/V Filter, Series 810 Large Adult Mask
WESTMED, INC.
8229
In Commercial Distribution

  • 10709078010726 ()
  • 00709078010729 ()


  • Anaesthesia breathing circuit, single-use
96" Pediatric Anesthesia Circuit, GSE, w/Cap, Parallel WYE, GSL 10' x .060" ID M/M 1L Not made with latex breathing bag, B/V Filter, In-Line Mini HME
WESTMED, INC.
9435
In Commercial Distribution

  • 10709078010139 ()
  • 00709078010132 ()


  • Anaesthesia breathing circuit, single-use
Anesthesia Expandable Circuit, Adult, 96", Parallel Wye, Angled HME, B/V Filter, 10' PVC x .050" ID M/M GSL, 3L Latex Free Bag, 900 Series Large Adult Mask
WESTMED, INC.
9279
In Commercial Distribution

  • 10709078009812 ()
  • 00709078009815 ()


  • Anaesthesia breathing circuit, single-use
108" Adult Expandable Anesthesia Circuit, Parallel Wye, w/GSP, B/V Filter (2), GSE w/CAP, 3L not made with latex bag, 10' x .060" ID M/M GSL
WESTMED, INC.
9249
Not in Commercial Distribution

  • 10709078009768 ()
  • 00709078009761 ()


  • Anaesthesia breathing circuit, single-use
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