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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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b-ONE™ Primary Acetabular System - 00843575104182

Acetabular Reamers Sterilization Case
B-ONE ORTHO, CORP.
8819900300
In Commercial Distribution

  • 00843575104182 ()
8819900300

  • Surgical instrument/implant rack

b-ONE™ Primary Acetabular System - 00843575104144

Sterilization Case Lid
B-ONE ORTHO, CORP.
8819900000
In Commercial Distribution

  • 00843575104144 ()
8819900000

  • Surgical instrument/implant rack

SIC invent Dental Implant Systems - 04260516875134

SIC Surgical Tray, universal, empty
SIC invent AG
935516
In Commercial Distribution

  • 04260516875134 ()


  • Surgical instrument/implant rack

SIC invent Dental Implant Systems - 04260516871723

SIC Bracket for Depth Stops, equipped
SIC invent AG
935512
In Commercial Distribution

  • 04260516871723 ()


  • Surgical instrument/implant rack

Irix-A Lumbar Integrated Fusion System - M697X08000281

Irix A Implant Inserter Tip Caddy
Xtant Medical Holdings, Inc.
X080-0028
In Commercial Distribution

  • M697X08000280 ()
  • M697X08000281 ()


  • Surgical instrument/implant rack

Irix-A Lumbar Integrated Fusion System - M697X08000261

Irix A Screw Caddy
Xtant Medical Holdings, Inc.
X080-0026
In Commercial Distribution

  • M697X08000260 ()
  • M697X08000261 ()


  • Surgical instrument/implant rack

Irix-A Lumbar Integrated Fusion System - M697X08000081

Irix A Implant Carrier
Xtant Medical Holdings, Inc.
X080-0008
In Commercial Distribution

  • M697X08000080 ()
  • M697X08000081 ()


  • Surgical instrument/implant rack

Atrix-C Cervical Allograft Spacer - M697X09400231

ATRIX-C CORTICAL/CANCELLOUS IMPLANT SOFT CARRY CASE
Xtant Medical Holdings, Inc.
X094-0023
In Commercial Distribution

  • M697X09400231 ()


  • Surgical instrument/implant rack

Atrix-C Cervical Allograft Spacer - M697X09400071

SOFT CARRY CASE II, ATRIX-C SPACERS
Xtant Medical Holdings, Inc.
X094-0007
In Commercial Distribution

  • M697X09400071 ()


  • Surgical instrument/implant rack

A.L.P.S. mvX™ - 00196449033379

ANKLE SCREW RACK B
Tyber Medical LLC
770103060
In Commercial Distribution

  • 00196449033379 ()


  • Surgical instrument/implant rack
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