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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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Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3304, STENT, C-FLEX 7/10F x 24 CM B3301, STENT, C-FLEX, 7/10F X 26CM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
BK005
Not in Commercial Distribution

  • 20607915128153 ()


  • Ureteral stent-placement set
  • Polymeric ureteral stent
  • Ureteral catheter
  • Gastro-urological guidewire, single-use
No Description
Edwards Lifesciences LLC
6200T
In Commercial Distribution

  • 00690103188424 ()

  • ASSESSMENT OF SEPTAL LEAFLET LENGTH AND EVALUATION OF THE ANTERIOR LEAFLET SURFACE AREA 24 MILLIMETERS
6200T24

  • Mitral/tricuspid annuloplasty ring, open-surgery
CERTEX 4.5 X 24mm THREADED X 16mm SMOOTH X 40mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0296
Not in Commercial Distribution

  • M697X06702961 ()

  • Length: 40 Millimeter
  • Outer Diameter: 4.5 Millimeter
  • Length: 16 Millimeter
  • Length: 24 Millimeter


  • Spinal bone screw, non-bioabsorbable
CERTEX 4.5 X 24mm THREADED X 13mm SMOOTH X 37mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0295
Not in Commercial Distribution

  • M697X06702951 ()

  • Length: 13 Millimeter
  • Length: 24 Millimeter
  • Length: 37 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
CERTEX 4.5 X 24mm THREADED X 10mm SMOOTH X 34mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0294
Not in Commercial Distribution

  • M697X06702941 ()

  • Length: 34 Millimeter
  • Length: 24 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
CERTEX 4.5 X 16mm THREADED X 8mm SMOOTH X 24mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0280
Not in Commercial Distribution

  • M697X06702801 ()

  • Length: 8 Millimeter
  • Length: 16 Millimeter
  • Length: 24 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
CERTEX 3.5 X 24mm THREADED X 16mm SMOOTH X 40mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0266
Not in Commercial Distribution

  • M697X06702661 ()

  • Length: 16 Millimeter
  • Outer Diameter: 3.5 Millimeter
  • Length: 24 Millimeter
  • Length: 40 Millimeter


  • Spinal bone screw, non-bioabsorbable
CERTEX 3.5 X 24mm THREADED X 13mm SMOOTH X 37mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0265
Not in Commercial Distribution

  • M697X06702651 ()

  • Length: 37 Millimeter
  • Length: 24 Millimeter
  • Outer Diameter: 3.5 Millimeter
  • Length: 13 Millimeter


  • Spinal bone screw, non-bioabsorbable
CERTEX 3.5 X 24mm THREADED X 10mm SMOOTH X 34mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0264
Not in Commercial Distribution

  • M697X06702641 ()

  • Length: 10 Millimeter
  • Length: 34 Millimeter
  • Outer Diameter: 3.5 Millimeter
  • Length: 24 Millimeter


  • Spinal bone screw, non-bioabsorbable
CERTEX 3.5 X 16mm THREADED X 8mm SMOOTH X 24mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0250
Not in Commercial Distribution

  • M697X06702501 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 24 Millimeter
  • Length: 8 Millimeter
  • Length: 16 Millimeter


  • Spinal bone screw, non-bioabsorbable
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