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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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No Description
Tyber Medical LLC
PLIF 22mm x 8mm x 8mm x 0 °, PEEK, Sterile
In Commercial Distribution

  • M695302P22808S1 ()
302-P22808S

  • Metal-polymer composite spinal interbody fusion cage
No Description
Tyber Medical LLC
PLIF 28mm x 12mm x 17mm x 0 °, PEEK, Sterile
In Commercial Distribution

  • M69502P2817012S1 ()
02P2817012S

  • Metal-polymer composite spinal interbody fusion cage
No Description
Tyber Medical LLC
PLIF 28mm x 8mm x 15mm x 0 °, TyPEEK, Sterile
In Commercial Distribution

  • M695502P281508S1 ()
502-P281508-S

  • Metal-polymer composite spinal interbody fusion cage
HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053000562 ()
  • 00870053000568 ()
  • 50870053000563 ()
1020

  • Chitosan haemostatic agent, professional, non-bioabsorbable
ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 50870053000303 ()
  • 00870053000308 ()
1025

  • Chitosan haemostatic agent, professional, non-bioabsorbable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S0100-381
In Commercial Distribution

  • 00848665039139 ()


  • Orthopaedic bone wire
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0249
In Commercial Distribution

  • 00848665001150 ()


  • Fluted surgical drill bit, single-use, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S0100-000
In Commercial Distribution

  • 00848665000009 ()


  • Orthopaedic bone wire
No Description
W.H. Holden, Inc.
10-4754X
In Commercial Distribution

  • D928104754X0 ()


  • Dental elevator, tooth/root
No Description
W.H. Holden, Inc.
10-4753X
In Commercial Distribution

  • D928104753X0 ()


  • Dental elevator, tooth/root
No Description
W.H. Holden, Inc.
10-4752
In Commercial Distribution

  • D9281047520 ()


  • Dental elevator, tooth/root
No Description
W.H. Holden, Inc.
10-4751
In Commercial Distribution

  • D9281047510 ()


  • Dental elevator, tooth/root
No Description
W.H. Holden, Inc.
10-4714R
In Commercial Distribution

  • D928104714R0 ()


  • Dental elevator, tooth/root
No Description
W.H. Holden, Inc.
10-4714L
In Commercial Distribution

  • D928104714L0 ()


  • Dental elevator, tooth/root
No Description
W.H. Holden, Inc.
10-4713R
In Commercial Distribution

  • D928104713R0 ()


  • Dental elevator, tooth/root
No Description
W.H. Holden, Inc.
10-4713L
In Commercial Distribution

  • D928104713L0 ()


  • Dental elevator, tooth/root
No Description
W.H. Holden, Inc.
10-4712R
In Commercial Distribution

  • D928104712R0 ()


  • Dental elevator, tooth/root
No Description
W.H. Holden, Inc.
10-4712L
In Commercial Distribution

  • D928104712L0 ()


  • Dental elevator, tooth/root
No Description
W.H. Holden, Inc.
10-4711R
In Commercial Distribution

  • D928104711R0 ()


  • Dental elevator, tooth/root
No Description
W.H. Holden, Inc.
10-4711L
In Commercial Distribution

  • D928104711L0 ()


  • Dental elevator, tooth/root
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