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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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DIAMETER:10MM MALLEABLE PENILE PROSTHESIS
Rigicon, Inc.
RG1010
In Commercial Distribution


  • Outer Diameter: 10 Millimeter
RG1010

  • Rigid penile prosthesis
DIAMETER:11MM MALLEABLE PENILE PROSTHESIS
Rigicon, Inc.
RG1011
In Commercial Distribution


  • Outer Diameter: 11 Millimeter
RG1011

  • Rigid penile prosthesis
DIAMETER:9MM MALLEABLE PENILE PROSTHESIS
Rigicon, Inc.
RG1009
In Commercial Distribution


  • Outer Diameter: 9 Millimeter
RG1009

  • Rigid penile prosthesis
Large Bore 60 cc Syringe
INARI MEDICAL INC
99-102
In Commercial Distribution

99-102

  • Thrombectomy manual aspirator
miniRUMEL™ DEVICE, 25cm
LSI Solutions, Inc.
080995
In Commercial Distribution

  • 10850200006985 ()
  • 00850200006988 ()
  • 00850200006582 ()

  • Minimum suture length for use with the device: 75 centimeters
  • Length: 25 Centimeter
080995

  • Suture/ligature tightener, single-use
miniRUMEL™ DEVICE, 15cm
LSI Solutions, Inc.
080990
In Commercial Distribution

  • 10850200006978 ()
  • 00850200006971 ()
  • 00850200006582 ()

  • Length: 15 Centimeter
  • Minimum suture length for use with the device: 55 centimeters
080990

  • Suture/ligature tightener, single-use
No Description
Laboratoires Bodycad Inc
018-001
In Commercial Distribution

018-001

  • Unicondylar knee prosthesis
Steerable Sheath, Bi-Directional
KALILA MEDICAL, INC.
SS8FMB74
Not in Commercial Distribution



  • Haemostasis valve
Decellularized Bovine Pericardium
Artivion, Inc.
PFP6X8
In Commercial Distribution


  • Width: 6 Centimeter
  • Length: 8 Centimeter
PFP6X8

  • Cardiovascular patch, animal-derived
SLK BK BR 3-0 C-2 1N 30'x5 RN
TELEFLEX INCORPORATED
IPN027358
In Commercial Distribution

  • 34026704594116 ()
  • 14026704594112 ()
  • 04026704594115 ()

  • Length: 75 Centimeter
  • SILK /Needle C-2 Size-3-0
XRNS-413M5

  • Silk suture
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