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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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Spinal Jaxx Interbody Fusion Device - 00818956020764

5 mm Rotating Scraper
NEUROPRO SPINAL JAXX INC.
100001-305
In Commercial Distribution

  • 00818956020764 ()

  • Height: 5 Millimeter
100001-305

  • General external orthopaedic fixation system implantation kit, reusable

Arthrex® - 00888867207936

FIBERWIRE, #5, WHITE, 38"
ARTHREX, INC.
AR-7215
In Commercial Distribution

  • 00888867207936 ()
  • 10888867207933 ()
AR-7215

  • Polyolefin/fluoropolymer suture, multifilament

Healgen - 00816490022725

5 Panel DrugTest Cup
Healgen Scientific Limited Liability Company
HCDOAA-154
In Commercial Distribution

  • 20816490022729 ()
  • 10816490022722 ()
  • 00816490022725 ()
HCDOAA-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Healgen - 00816490022244

5 Panel DrugTest Cup
Healgen Scientific Limited Liability Company
HCDOAA-155
In Commercial Distribution

  • 20816490022248 ()
  • 10816490022241 ()
  • 00816490022244 ()
HCDOAA-155

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

EPIPHANY - B528PSE60140

EPIPHANY 5/1 PEEK
PANTHEON SPINAL, LLC
1
In Commercial Distribution

  • B528PSE60140 ()

  • Length: 60 Millimeter
  • Height: 14 Millimeter
PSE 60-14

  • Polymeric spinal interbody fusion cage

EPIPHANY - B528PSE60120

EPIPHANY 5/1 PEEK
PANTHEON SPINAL, LLC
1
In Commercial Distribution

  • B528PSE60120 ()

  • Length: 60 Millimeter
  • Height: 12 Millimeter
PSE 60-12

  • Polymeric spinal interbody fusion cage

EPIPHANY - B528PSE60100

EPIPHANY 5/1 PEEK
PANTHEON SPINAL, LLC
1
In Commercial Distribution

  • B528PSE60100 ()

  • Height: 10 Millimeter
  • Length: 60 Millimeter
PSE 60-10

  • Polymeric spinal interbody fusion cage

EPIPHANY - B528PSE60080

EPIPHANY 5/1 PEEK
PANTHEON SPINAL, LLC
1
In Commercial Distribution

  • B528PSE60080 ()

  • Length: 60 Millimeter
  • Height: 8 Millimeter
PSE 60-08

  • Polymeric spinal interbody fusion cage

EPIPHANY - B528PSE40140

EPIPHANY 5/1 PEEK
PANTHEON SPINAL, LLC
1
In Commercial Distribution

  • B528PSE40140 ()

  • Length: 40 Millimeter
  • Height: 14 Millimeter
PSE 40-14

  • Polymeric spinal interbody fusion cage

Epiphany - B528PSE40100

Epiphany 5/1 PEEK
PANTHEON SPINAL, LLC
1
In Commercial Distribution

  • B528PSE40100 ()

  • Height: 10 Millimeter
  • Length: 40 Millimeter
PSE 40-10

  • Polymeric spinal interbody fusion cage
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