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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 - M697X08038281724STR1

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

  • M697X08038281724STR1 ()

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


  • Metal-polymer composite spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08033261724STR1

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

  • M697X08033261724STR1 ()

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


  • Metal-polymer composite spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08038281924STR1

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

  • M697X08038281924STR1 ()

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


  • Metal-polymer composite spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08033261924STR1

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

  • M697X08033261924STR1 ()

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


  • Metal-polymer composite spinal interbody fusion cage

Novo Surgical Inc. - 00842331146916

dittel urethral sound, straight, 11 1/2" (29.2 cm), 24 fr.
NOVO SURGICAL, INC.
UR6271-35L
In Commercial Distribution

  • 00842331146916 ()
UR6271-35L

  • Urethral dilator, reusable

NA - 04042409445408

Cannulated Headless Bone Screw 2.5, L 24, TL 10 long, Titanium
aap Implantate AG
SH 2510-24-2
In Commercial Distribution

  • 04042409445408 ()


  • Orthopaedic bone screw (non-sliding)

NA - 04042409445187

Cannulated Headless Bone Screw 2.5, L 24, TL 6 short, Titanium
aap Implantate AG
SH 2506-24-2
In Commercial Distribution

  • 04042409445187 ()


  • Orthopaedic bone screw (non-sliding)

NA - 04042409398056

Cancellous Screw 4.0, small head, T15, full thread, L 24 Titanium
aap Implantate AG
SP 4035-24-2
In Commercial Distribution

  • 04042409398056 ()
SP 4035-24-2

  • Orthopaedic bone screw (non-sliding)

Ambler Surgical - 00190660030261

Hank uterine dilator, 11'', double-ended, size 23/24 French, round handle
AMBLER SURGICAL CORP.
Hank uterine dilator
In Commercial Distribution

  • 00190660030261 ()
44-736

  • Fixed-diameter cervical dilator, reusable

General Instruments - 00840180504291

C-C Angled ALIF TRIAL, 10 x 34 x 24 mm, 15°
ALPHATEC SPINE, INC.
CI-10479-114-10342415
In Commercial Distribution

  • 00840180504291 ()

  • Length: 24 Millimeter
  • Width: 34 Millimeter
  • Height: 10 Millimeter
  • Angle: 15 degree


  • Spinal implant trial
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