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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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ALIF Instrument Case
NEXXT SPINE, LLC
C60-01-01
In Commercial Distribution

  • 00889929039588 ()


  • Device sterilization/disinfection container, reusable
Lateral Access, Case
NEXXT SPINE, LLC
C62-01-03
In Commercial Distribution

  • 00889929038789 ()


  • Device sterilization/disinfection container, reusable
STERILIZATION CASE, SILEX
Xtant Medical Holdings, Inc.
X079-0003
In Commercial Distribution

  • M697X07900030 ()
  • M697X07900031 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Sterilization Case, Xpress
Xtant Medical Holdings, Inc.
X073-0008
In Commercial Distribution

  • M697X07300080 ()
  • M697X07300081 ()


  • Device sterilization/disinfection container, reusable
Sterilization Case, Zygafix
Xtant Medical Holdings, Inc.
X076-0003
In Commercial Distribution

  • M697X07600030 ()
  • M697X07600031 ()


  • Device sterilization/disinfection container, reusable
FIXCET STERILIZATION CASE
Xtant Medical Holdings, Inc.
X063-0002
In Commercial Distribution

  • M697X06300020 ()
  • M697X06300021 ()


  • Device sterilization/disinfection container, reusable
Staple System Case
Trimed, INC.
TSS-CASE
In Commercial Distribution

  • 00842188113222 ()
TSS-CASE

  • Instrument tray, reusable
Calix Sterilization Case
Xtant Medical Holdings, Inc.
X003-0002
In Commercial Distribution

  • M697X00300020 ()
  • M697X00300021 ()


  • Polymeric spinal interbody fusion cage
X-PORT, Sterilization Case
Xtant Medical Holdings, Inc.
X014-0015
In Commercial Distribution

  • M697X01400150 ()
  • M697X01400151 ()


  • Bone-screw internal spinal fixation system, non-sterile
SHS IMPLANT CASE
ORTHOPAEDIC IMPLANT COMPANY, THE
01-SHS022
In Commercial Distribution

  • M69601SHS0220 ()


  • Device sterilization/disinfection container, reusable
SHS INSTRUMENT CASE
ORTHOPAEDIC IMPLANT COMPANY, THE
01-SHS020
In Commercial Distribution

  • M69601SHS0200 ()


  • Device sterilization/disinfection container, reusable
Instrument Case 1
ALPHANOX CO.,LTD.
9901-4030
In Commercial Distribution

  • 08806373581311 ()
9901-4030

  • Device sterilization/disinfection container, reusable
SpineCraft Case Lid
SPINECRAFT, LLC
6600-LID
In Commercial Distribution

  • 00193082154706 ()
6600-LID

  • General internal orthopaedic fixation system implantation kit
Radiofrequency Autoclave Case
Avanos Medical, Inc.
PMA-AC-100675
In Commercial Distribution

  • 10193493985927 ()
  • 00193493985920 ()
PMA-AC-100675

  • Device sterilization/disinfection container, reusable
Instrument Case 2
ALPHANOX CO.,LTD.
9901-4031
In Commercial Distribution

  • 08806373581328 ()
9901-4031

  • Device sterilization/disinfection container, reusable
LONG ALUMINUM CASE
Synthes GmbH
301.96
In Commercial Distribution

  • H679301960 ()
  • 10886982182739 ()
30196

  • Surgical instrument/implant rack
STERILIZATION CASE #1
Exactech, Inc.
400-93-02
In Commercial Distribution

  • 10885862090461 ()
400-93-02

  • Instrument tray, reusable
STERILIZATION CASE #2
Exactech, Inc.
400-93-03
In Commercial Distribution

  • 10885862090478 ()
400-93-03

  • Instrument tray, reusable
Hip Sterilization Case
Medos International Sàrl
215509
In Commercial Distribution

  • 10886705021871 ()
215509

  • Instrument tray, reusable
Sterilization Case Lid
Medos International Sàrl
254848
In Commercial Distribution

  • 10886705027941 ()
254848

  • Instrument tray, reusable
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