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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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Mirror™ - M543100296

Tibial baseplate with pegs (LM/RL-48mm)
CAYENNE MEDICAL, INC.
100296
Not in Commercial Distribution

  • M543100296 ()


  • Uncoated unicondylar knee tibia prosthesis, metallic

Mirror™ - M543100295

Tibial baseplate with pegs (RM/LL-44mm)
CAYENNE MEDICAL, INC.
100295
Not in Commercial Distribution

  • M543100295 ()


  • Uncoated unicondylar knee tibia prosthesis, metallic

Mirror™ - M543100294

Tibial baseplate with pegs (LM/RL-44mm)
CAYENNE MEDICAL, INC.
100294
Not in Commercial Distribution

  • M543100294 ()


  • Uncoated unicondylar knee tibia prosthesis, metallic

RX Biliary - 08714729252221

Biliary Stent with RX Delivery System
BOSTON SCIENTIFIC CORPORATION
M00545650
In Commercial Distribution

  • 08714729252221 ()

  • 8.5 F Diameter
  • 5 cm Effective Length
  • 2.8 mm Diameter


  • Polymeric biliary stent, non-bioabsorbable

Flexima™ - 08714729191858

Biliary Catheter System with Dissolving Tip
BOSTON SCIENTIFIC CORPORATION
M001281590
In Commercial Distribution

  • 08714729191858 ()

  • 35 cm Effective Length
  • 14 F Diameter
M001281590

  • Biliary drain

Flexima™ - 08714729191841

Biliary Catheter System with Dissolving Tip
BOSTON SCIENTIFIC CORPORATION
M001281570
In Commercial Distribution

  • 08714729191841 ()

  • 10 F Diameter
  • 35 cm Effective Length
M001281570

  • Biliary drain

Flexima™ - 08714729191834

Biliary Catheter System with Dissolving Tip
BOSTON SCIENTIFIC CORPORATION
M001281560
In Commercial Distribution

  • 08714729191834 ()

  • 8 F Diameter
  • 35 cm Effective Length
M001281560

  • Biliary drain

Flexima™ APDL - 08714729191827

Drainage Catheter System with Dissolving Tip
BOSTON SCIENTIFIC CORPORATION
M001281390
In Commercial Distribution

  • 08714729191827 ()

  • 14 F Diameter
  • 25 cm Effective Length


  • Biliary drain
  • Mediastinal drainage catheter, non-antimicrobial
  • Nephrostomy catheter
  • Pleural catheter

Flexima™ APD™ - 08714729191810

Drainage Catheter System with Dissolving Tip
BOSTON SCIENTIFIC CORPORATION
M001281370
In Commercial Distribution

  • 08714729191810 ()

  • 14 F Diameter
  • 25 cm Effective Length


  • Nephrostomy catheter
  • Biliary drain
  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial

Flexima™ APD™ - 08714729191803

Drainage Catheter System with Dissolving Tip
BOSTON SCIENTIFIC CORPORATION
M001281360
In Commercial Distribution

  • 08714729191803 ()

  • 25 cm Effective Length
  • 12 F Diameter


  • Pleural catheter
  • Biliary drain
  • Nephrostomy catheter
  • Mediastinal drainage catheter, non-antimicrobial
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