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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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TO BE ASSIGNED - 00887661522146

No Description
FGX INTERNATIONAL INC.
10241225.FMR
In Commercial Distribution

  • 00887661522146 ()


  • Tinted non-prescription spectacles

Point To Hole - 00887868570629

No Description
Biomet Orthopedics, LLC
110010400
In Commercial Distribution

  • 00887868570629 ()
110010400

  • Orthopaedic implant aiming arm

Point To Point - 00887868570612

No Description
Biomet Orthopedics, LLC
110010399
In Commercial Distribution

  • 00887868570612 ()
110010399

  • Orthopaedic implant aiming arm

ENDOSKELETON® TO - 00191375052531

Modular Head Trial Remover
MEDTRONIC SOFAMOR DANEK, INC.
1000-0211
In Commercial Distribution

  • 00191375052531 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

ENDOSKELETON® TO - 00191375052111

Caddy, Base
MEDTRONIC SOFAMOR DANEK, INC.
920-042-002
In Commercial Distribution

  • 00191375052111 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375052104

Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
920-041-001
In Commercial Distribution

  • 00191375052104 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375052098

Perforated, Tray, Base
MEDTRONIC SOFAMOR DANEK, INC.
920-020-001
In Commercial Distribution

  • 00191375052098 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375052067

Perforated, Tray, Base
MEDTRONIC SOFAMOR DANEK, INC.
863-020-001
In Commercial Distribution

  • 00191375052067 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051893

Perforated, Tray, Base
MEDTRONIC SOFAMOR DANEK, INC.
588-020-001
In Commercial Distribution

  • 00191375051893 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051886

Lower, Inner Tray
MEDTRONIC SOFAMOR DANEK, INC.
587-030-201
In Commercial Distribution

  • 00191375051886 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051879

Perforated, Tray, Base
MEDTRONIC SOFAMOR DANEK, INC.
587-020-001
In Commercial Distribution

  • 00191375051879 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051862

Upper, Inner Tray
MEDTRONIC SOFAMOR DANEK, INC.
586-030-201
In Commercial Distribution

  • 00191375051862 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051855

Lower, Inner Tray
MEDTRONIC SOFAMOR DANEK, INC.
586-030-101
In Commercial Distribution

  • 00191375051855 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051848

Perforated, Tray, Base
MEDTRONIC SOFAMOR DANEK, INC.
586-020-001
In Commercial Distribution

  • 00191375051848 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051831

Instrument Case
TITAN SPINE, LLC
586-000-001
Not in Commercial Distribution

  • 00191375051831 ()
586-000-001

  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051633

Lordotics, Odds, PLIF, Implant Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
3900-1004-10
In Commercial Distribution

  • 00191375051633 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051626

Lordotics, Odds, PLIF, Implant Caddy, Base
MEDTRONIC SOFAMOR DANEK, INC.
3900-1004-05
In Commercial Distribution

  • 00191375051626 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051619

0 Deg, Convex, Implant Caddy, Lid, Oblique
MEDTRONIC SOFAMOR DANEK, INC.
3900-1003-10
In Commercial Distribution

  • 00191375051619 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051602

0 Deg, Convex, Implant Caddy, Base, Oblique
MEDTRONIC SOFAMOR DANEK, INC.
3900-1003-05
In Commercial Distribution

  • 00191375051602 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051596

Convex, Odds, PLIF, Implant Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
3900-1002-10
In Commercial Distribution

  • 00191375051596 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051589

Convex, Odds, PLIF, Implant Caddy, Base
MEDTRONIC SOFAMOR DANEK, INC.
3900-1002-05
In Commercial Distribution

  • 00191375051589 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051572

0 Deg, Convex, Implant Caddy, Lid, Oblique
MEDTRONIC SOFAMOR DANEK, INC.
3900-1001-72
In Commercial Distribution

  • 00191375051572 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051565

0 Deg, Convex, Implant Caddy, Base, Oblique
MEDTRONIC SOFAMOR DANEK, INC.
3900-1001-71
In Commercial Distribution

  • 00191375051565 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051558

Evens, Lordotic, PLIF, Implant Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
3900-1001-62
In Commercial Distribution

  • 00191375051558 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051541

Evens, Lordotic, PLIF, Implant Caddy, Base
MEDTRONIC SOFAMOR DANEK, INC.
3900-1001-61
In Commercial Distribution

  • 00191375051541 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051534

Convex, Evens, PLIF, Implant Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
3900-1001-52
In Commercial Distribution

  • 00191375051534 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051527

Convex, Evens, PLIF, Implant Caddy, Base
MEDTRONIC SOFAMOR DANEK, INC.
3900-1001-51
In Commercial Distribution

  • 00191375051527 ()


  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375051510

Tray Implant Holder (base)
TITAN SPINE, LLC
3900-1001-10
Not in Commercial Distribution

  • 00191375051510 ()
3900-1001-10

  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375032229

Trial, PLIF, 16mm
TITAN SPINE, LLC
3210-2216
Not in Commercial Distribution

  • 00191375032229 ()

  • Depth: 9 Millimeter
  • Height: 16 Millimeter
  • width(MLxAP), 22 x 9, mm
  • Width: 22 Millimeter
3210-2216

  • Spinal implant trial

ENDOSKELETON® TO - 00191375031116

Trial, Oblique, 16mm
TITAN SPINE, LLC
3210-3116
Not in Commercial Distribution

  • 00191375031116 ()

  • width(MLxAP), 31 x 11, mm
  • Depth: 11 Millimeter
  • Height: 16 Millimeter
  • Width: 31 Millimeter
3210-3116

  • Spinal implant trial
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