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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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PACKING SET, NEURO2 ZTI EXCHANGE BOX C044
NEURELEC
181517
In Commercial Distribution

  • 03663227001754 ()


  • Cochlear implant/auditory brainstem implant sound processor
RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN930196
In Commercial Distribution

  • 20801902221340 ()
  • 10801902221343 ()
RC-09850

  • Vascular catheter introduction set, nonimplantable
RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN930195
In Commercial Distribution

  • 20801902221333 ()
  • 10801902221336 ()
RC-09700

  • Vascular catheter introduction set, nonimplantable
RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN920421
In Commercial Distribution

  • 20801902194637 ()
  • 10801902194630 ()
RC-09700

  • Vascular catheter introduction set, nonimplantable
RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN920128
In Commercial Distribution

  • 20801902193494 ()
  • 10801902193497 ()
RC-09850

  • Vascular catheter introduction set, nonimplantable
RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN923914
In Commercial Distribution

  • 20801902207122 ()
  • 10801902207125 ()
RC-09850

  • Vascular catheter introduction set, nonimplantable
RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN923913
In Commercial Distribution

  • 20801902207115 ()
  • 10801902207118 ()
RC-09700

  • Vascular catheter introduction set, nonimplantable
Cook Airway Exchange Catheter with Rapi-Fit Adapters
COOK INCORPORATED
G57628
In Commercial Distribution

  • 00827002576285 ()
C-CAE-14.0-100-DLT-EF-ST-01

  • Endotracheal tube guide, single-use
Cook Airway Exchange Catheter with Rapi-Fit Adapters
COOK INCORPORATED
G57627
In Commercial Distribution

  • 00827002576278 ()
C-CAE-11.0-100-DLT-EF-ST-01

  • Endotracheal tube guide, single-use
Cook Airway Exchange Catheter with Rapi-Fit Adapters
COOK INCORPORATED
G57624
In Commercial Distribution

  • 00827002576247 ()
C-CAE-8.0-45-01

  • Endotracheal tube guide, single-use
Cook Airway Exchange Catheter with Rapi-Fit Adapters
COOK INCORPORATED
G57623
In Commercial Distribution

  • 00827002576230 ()
C-CAE-19.0-83-01

  • Endotracheal tube guide, single-use
Cook Airway Exchange Catheter with Rapi-Fit Adapters
COOK INCORPORATED
G57622
In Commercial Distribution

  • 00827002576223 ()
C-CAE-14.0-83-01

  • Endotracheal tube guide, single-use
Cook Airway Exchange Catheter with Rapi-Fit Adapters
COOK INCORPORATED
G57621
In Commercial Distribution

  • 00827002576216 ()
C-CAE-11.0-83-01

  • Endotracheal tube guide, single-use
HydroMax, Disposable, Heat and Moisture Exchange Filter
A-M SYSTEMS, LLC
HydroMax - 158200
In Commercial Distribution

  • 00817081020502 ()
  • 00817081020496 ()
158200

  • Heat/moisture exchanger/microbial medical gas filter
CABLE CAMERA W/TOOL F/HEAD EXCHANGE
JEDMED INSTRUMENT COMPANY
70-6521
In Commercial Distribution

  • M6337065210 ()
70-6521

  • Throat microphone
RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN033580
In Commercial Distribution

  • 30801902101526 ()
  • 00801902101525 ()
RC-09850

  • Vascular catheter introduction set, nonimplantable
RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN033578
In Commercial Distribution

  • 30801902101519 ()
  • 00801902101518 ()
RC-09700

  • Vascular catheter introduction set, nonimplantable
RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN033579
In Commercial Distribution

  • 30801902001376 ()
  • 00801902001375 ()
RC-09850

  • Vascular catheter introduction set, nonimplantable
RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN033577
In Commercial Distribution

  • 30801902001369 ()
  • 00801902001368 ()
RC-09700

  • Vascular catheter introduction set, nonimplantable
Xper Flex Cardio 2020 Rev D Exchange
Philips Ds North America LLC
Xper Flex Cardio 2020 Rev D Exchange
In Commercial Distribution

  • 00884838086012 ()
453564675001

  • General-purpose multi-parameter bedside monitor
Xper Flex Cardio 2020 Rev E Exchange
Philips Ds North America LLC
Xper Flex Cardio 2020 Rev E Exchange
Not in Commercial Distribution

  • 00884838093782 ()
453564845861

  • General-purpose multi-parameter bedside monitor
For Therapeutic Plasma Exchange (TPE) Procedure. For Red Blood Cell Exchange (RBCX) Procedures. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
X6R2349
In Commercial Distribution

  • 04086000101950 ()
  • 14086000101957 ()
X6R2349

  • Therapeutic plasma/red blood cell exchange tubing set
No Description
Merit Medical Systems, Inc.
00884450239476
In Commercial Distribution

  • 10884450239473 ()
  • 00884450239476 ()
  • 20884450239470 ()

  • Tip Shape-3 mm J-Tip
  • Length-260 cm (102")
  • Configuration-Amplatz Exchange
  • Length-260 cm (102"); Tip Shape-3 mm J-Tip; Length-260 cm (102"); Configuration-Amplatz Exchange
  • Configuration-Amplatz Exchange; Tip Shape-3 mm J-Tip; Length-260 cm (102"); Configuration-Amplatz Exchange
IQA502

  • Cardiac/peripheral vascular guidewire, single-use
BladderScan® Prime Plus™ Probe, Probe Exchange
VERATHON INC
Prime Plus™
In Commercial Distribution

  • 10879123008012 ()
  • 00879123008015 ()
E570-0395

  • Bladder ultrasound imaging transducer
Cystoscope 2.9 x 365 mm, 0°, Factory Exchange
SCHÖLLY FIBEROPTIC GmbH
UL-SCOPE-FE
In Commercial Distribution

  • 04250480106563 ()

  • Insertion tube outer diameter 2.9 mm
  • Working length 365 mm
  • Direction of view 0 Degree


  • Rigid optical cystoscope
Cystoscope 4 x 302 mm, 0°, Factory exchange
SCHÖLLY FIBEROPTIC GmbH
UL-SCOPE4-0-FE
In Commercial Distribution

  • 04250480107959 ()

  • Insertion tube outer diameter 4 mm
  • Working length 302 mm
  • Direction of view 0 Degree


  • Rigid optical cystoscope
Cystoscope 4 x 302 mm, 30°, Factory Exchange
SCHÖLLY FIBEROPTIC GmbH
UL-SCOPE4-FE
In Commercial Distribution

  • 04250480106587 ()

  • Direction of view 30 Degree
  • Working length 302 mm
  • Insertion tube outer diameter 4 mm


  • Rigid optical cystoscope
Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49333
Not in Commercial Distribution

  • 10827002493336 ()
ZIVX5-18-125-10-80

  • Peripheral artery stent, bare-metal
Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49332
Not in Commercial Distribution

  • 10827002493329 ()
ZIVX5-18-125-10-60

  • Peripheral artery stent, bare-metal
Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49331
Not in Commercial Distribution

  • 10827002493312 ()
ZIVX5-18-125-10-40

  • Peripheral artery stent, bare-metal
Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49330
Not in Commercial Distribution

  • 10827002493305 ()
ZIVX5-18-125-10-30

  • Peripheral artery stent, bare-metal
Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49329
Not in Commercial Distribution

  • 10827002493299 ()
ZIVX5-18-125-10-20

  • Peripheral artery stent, bare-metal
Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49328
Not in Commercial Distribution

  • 10827002493282 ()
ZIVX5-18-125-9-80

  • Peripheral artery stent, bare-metal
Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49327
Not in Commercial Distribution

  • 10827002493275 ()
ZIVX5-18-125-9-60

  • Peripheral artery stent, bare-metal
Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49326
Not in Commercial Distribution

  • 10827002493268 ()
ZIVX5-18-125-9-40

  • Peripheral artery stent, bare-metal
Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49325
Not in Commercial Distribution

  • 10827002493251 ()
ZIVX5-18-125-9-30

  • Peripheral artery stent, bare-metal
Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49324
Not in Commercial Distribution

  • 10827002493244 ()
ZIVX5-18-125-9-20

  • Peripheral artery stent, bare-metal
Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49323
Not in Commercial Distribution

  • 10827002493237 ()
ZIVX5-18-125-8-80

  • Peripheral artery stent, bare-metal
Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49322
Not in Commercial Distribution

  • 10827002493220 ()
ZIVX5-18-125-8-60

  • Peripheral artery stent, bare-metal
Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49321
Not in Commercial Distribution

  • 10827002493213 ()
ZIVX5-18-125-8-40

  • Peripheral artery stent, bare-metal
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