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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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Romero Lordotic Rasp with Stop 16x14, H11 mm
Spineup, Inc.
RO0147L21116X14
In Commercial Distribution

  • B806RO0147L21116X140 ()

  • Height: 11 Millimeter
  • Width: 16 Millimeter
  • Depth: 14 Millimeter
RO0147L21116X14

  • Bone file/rasp, manual, reusable
Romero Lordotic Rasp with Stop 16x14, H10 mm
Spineup, Inc.
RO0146L21016X14
In Commercial Distribution

  • B806RO0146L21016X140 ()

  • Height: 10 Millimeter
  • Width: 16 Millimeter
  • Depth: 14 Millimeter
RO0146L21016X14

  • Bone file/rasp, manual, reusable
Romero Lordotic Rasp with Stop 16x14, H09 mm
Spineup, Inc.
RO0145L20916X14
In Commercial Distribution

  • B806RO0145L20916X140 ()

  • Height: 09 Millimeter
  • Width: 16 Millimeter
  • Depth: 14 Millimeter
RO0145L20916X14

  • Bone file/rasp, manual, reusable
Romero Lordotic Rasp with Stop 16x14, H08 mm
Spineup, Inc.
RO0144L20816X14
In Commercial Distribution

  • B806RO0144L20816X140 ()

  • Height: 08 Millimeter
  • Width: 16 Millimeter
  • Depth: 14 Millimeter
RO0144L20816X14

  • Bone file/rasp, manual, reusable
Romero Lordotic Rasp with Stop 16x14, H07 mm
Spineup, Inc.
RO0143L20716X14
In Commercial Distribution

  • B806RO0143L20716X140 ()

  • Height: 07 Millimeter
  • Width: 16 Millimeter
  • Depth: 14 Millimeter
RO0143L20716X14

  • Bone file/rasp, manual, reusable
Romero Lordotic Rasp with Stop 16x14, H06 mm
Spineup, Inc.
RO0142L20616X14
In Commercial Distribution

  • B806RO0142L20616X140 ()

  • Height: 06 Millimeter
  • Width: 16 Millimeter
  • Depth: 14 Millimeter
RO0142L20616X14

  • Bone file/rasp, manual, reusable
Radiological visualization software for diagnosis and dental treatment planning
SiCAT GmbH & Co. KG
6455641
Not in Commercial Distribution

  • D77664556410 ()
6455641

  • Diagnostic x-ray digital imaging system workstation
No Description
SiCAT GmbH & Co. KG
6455633
Not in Commercial Distribution

  • D77664556330 ()
6455633

  • Diagnostic x-ray digital imaging system workstation
EchoMark is an implantable ultrasound surgical site marker for soft tissue. The marker is comprised of a bioresorbable polymer.
SONAVEX, INC.
3000
In Commercial Distribution

  • B53630001 ()

  • Large


  • Radiological image marker, implantable
EchoMark LP is an implantable ultrasound surgical site marker for soft tissue. The marker is comprised of a bioresorbable polymer.
SONAVEX, INC.
2000
In Commercial Distribution

  • B53620001 ()

  • Small


  • Radiological image marker, implantable
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