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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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Integra® Miltex® - 10381780478836

Integra® Miltex® Walther Urethral Sound, 11-1/4", 24 French
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
29-18-24
In Commercial Distribution

  • H8342918240 ()
  • 10381780478836 ()

  • Catheter Gauge: 24 French
  • 11-1/4"
29-18-24

  • Urethral sound, reusable

Integra® Miltex® - 10381780478706

Integra® Miltex® Lefort Urethral Sound, 10-1/2", 24 French
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
29-10-24
In Commercial Distribution

  • H8342910240 ()
  • 10381780478706 ()
29-10-24

  • Urethral sound, reusable

Integra® Jarit® - 10381780406549

Integra® Jarit® Walther Female Dilator-Catheter, 5-1/2", 24 French
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X304435
In Commercial Distribution

  • M274X3044351 ()
  • 10381780406549 ()

  • Catheter Gauge: 24 French
  • 5-1/2"
X304435

  • Urethral sound, reusable

Integra® Jarit® - 10381780406365

Integra® Jarit® Walther Urethral Sound, 11-1/4", 24 French
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X302935
In Commercial Distribution

  • M274X3029351 ()
  • 10381780406365 ()

  • Catheter Gauge: 24 French
  • 11-1/4"
X302935

  • Urethral sound, reusable

Integra® Jarit® - 10381780406273

Integra® Jarit® Lefort Urethral Sound, 10-1/2", 24 French
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X302135
In Commercial Distribution

  • M274X3021351 ()
  • 10381780406273 ()
X302135

  • Urethral sound, reusable

Omni-Tract® - 10381780272618

Omni-Tract® 24" x 36" compress, rayon / cellulose wrapped in Gauze
INTEGRA LIFESCIENCES CORPORATION
11908
In Commercial Distribution

  • M248119081 ()
  • 10381780272618 ()
11908

  • Surgical retraction system, reusable

Irix-A Lumbar Integrated Fusion System - M697X08042301924TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 24°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423019-24T-STR
In Commercial Distribution

  • M697X08042301924TSTR1 ()

  • 30mm depth X 24°, 19mm height
  • Width: 42 Millimeter


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301724TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 24°, 17mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423017-24T-STR
In Commercial Distribution

  • M697X08042301724TSTR1 ()

  • 30mm depth X 24°, 17mm height
  • Width: 42 Millimeter


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301524TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 24°, 15mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423015-24T-STR
In Commercial Distribution

  • M697X08042301524TSTR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 24°, 15mm height


  • Metallic spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08038281924TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 24°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382819-24T-STR
In Commercial Distribution

  • M697X08038281924TSTR1 ()

  • 28mm depth X 24°, 19mm height
  • Width: 38 Millimeter


  • Metallic spinal interbody fusion cage
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