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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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Irix-A Lumbar Integrated Fusion System - M697X08038281524TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 24°, 15mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382815-24T-STR
In Commercial Distribution

  • M697X08038281524TSTR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 24°, 15mm height


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08033261724TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 24°, 17mm (STERILE)
Xtant Medical Holdings, Inc.
X080-332617-24T-STR
In Commercial Distribution

  • M697X08033261724TSTR1 ()

  • 26mm depth X 24°, 17mm height
  • Width: 33 Millimeter


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08033261524TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 24°, 15mm (STERILE)
Xtant Medical Holdings, Inc.
X080-332615-24T-STR
In Commercial Distribution

  • M697X08033261524TSTR1 ()

  • Width: 33 Millimeter
  • 26mm depth X 24°, 15mm height


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08038281724TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 24°, 17mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382817-24T-STR
In Commercial Distribution

  • M697X08038281724TSTR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 24°, 17mm height


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08033261924TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 24°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-332619-24T-STR
In Commercial Distribution

  • M697X08033261924TSTR1 ()

  • Width: 33 Millimeter
  • 26mm depth X 24°, 19mm height


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08033261324TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 24°, 13mm (STERILE)
Xtant Medical Holdings, Inc.
X080-332613-24T-STR
In Commercial Distribution

  • M697X08033261324TSTR1 ()

  • 26mm depth X 24°, 13mm height
  • Width: 33 Millimeter


  • Metallic spinal interbody fusion cage

Ceri-Prime - D8130301255000

PORCELAIN REPAIR/PFM KIT
DEN-MAT HOLDINGS, LLC
030125500
In Commercial Distribution

  • D8130301255000 ()
030125500

  • Dental etching solution

Malar Implant - B049M24S0

Non-sterile, silicone, malar implant, sizer, pair.
Hanson Medical, Inc.
M 2-4 S
In Commercial Distribution

  • B049M24S0 ()
M 2-4 S

  • Malar prosthesis

Chin Implant - B049CH24S0

Non-sterile, silicone, chin implant, sizer.
Hanson Medical, Inc.
CH 2-4 S
In Commercial Distribution

  • B049CH24S0 ()
CH 2-4 S

  • Chin prosthesis

Pectoralis Implant - B049ACP24R0

Non-sterile, silicone, pectoralis implant, right.
Hanson Medical, Inc.
ACP 2-4 R
In Commercial Distribution

  • B049ACP24R0 ()
ACP 2-4 R

  • Pectoral implant, non-sterile
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