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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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Artic 8, BL3 / 0 degree - 30 L, CE - J014669704430

Artifical Teeth, resin
Kulzer GmbH
66970443
In Commercial Distribution

  • J014669704430 ()
66970443

  • Resin artificial teeth

Artic 8, BL3 / 0 degree - 30 U, CE - J014669704420

Artifical Teeth, resin
Kulzer GmbH
66970442
In Commercial Distribution

  • J014669704420 ()
66970442

  • Resin artificial teeth

Artic 8, BL3 / 20 degree - 30 L, CE - J014669704370

Artifical Teeth, resin
Kulzer GmbH
66970437
In Commercial Distribution

  • J014669704370 ()
66970437

  • Resin artificial teeth

Artic 8, BL3 / 20 degree - 30 U, CE - J014669704360

Artifical Teeth, resin
Kulzer GmbH
66970436
In Commercial Distribution

  • J014669704360 ()
66970436

  • Resin artificial teeth

Integra® Ruggles®-Redmond™ - 10381780200222

Integra® Ruggles®-Redmond™ Spinal Curette, 8", Angled, Size 3-0
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
RE0822
In Commercial Distribution

  • M274RE08221 ()
  • 10381780200222 ()
RE0822

  • Bone curette, reusable

Integra® Ruggles®-Redmond™ - 10381780194811

Integra® Ruggles®-Redmond™ Spinal Curette, 8", Straight, Size 3-0
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
RE0802
In Commercial Distribution

  • M274RE08021 ()
  • 10381780194811 ()
RE0802

  • Bone curette, reusable

Integra® Jarit® - 10381780187219

Integra® Jarit® Bruns Oval Cup Curette, 8", Angled, Size 3-0
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
240087
In Commercial Distribution

  • M2742400871 ()
  • 10381780187219 ()
240-087

  • Bone curette, reusable

Integra® Jarit® - 10381780185109

Integra® Jarit® Bruns Oval Cup Curette, 8", Straight, Size 3-0
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
240072
In Commercial Distribution

  • M2742400721 ()
  • 10381780185109 ()
240-072

  • Bone curette, reusable

Axle Interspinous Fusion System - M697X08042301708X1

IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 17mm, CE MARKED
Xtant Medical Holdings, Inc.
X080-423017-08X
In Commercial Distribution

  • M697X08042301708X1 ()

  • Width: 42 Millimeter
  • Angle: 8 degree
  • Height: 17 Millimeter
  • Length: 30 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08042301708TPC1

IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 42 X 30 X 8°, 17mm, PC
Xtant Medical Holdings, Inc.
X080-423017-08TPC
Not in Commercial Distribution

  • M697X08042301708TPC1 ()

  • Width: 42 Millimeter
  • Angle: 8 degree
  • Height: 17 Millimeter
  • Length: 30 Millimeter


  • Metallic spinal interbody fusion cage
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