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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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NexFix™ - 00846832007325

No Description
TORNIER, INC.
NCS-4028
In Commercial Distribution

  • 00846832007325 ()

  • Outer Diameter: 4.5 Millimeter
  • Thickness 9 mm
  • Length: 28 Millimeter
NCS-4028

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Futura - 00846832014248

TRIAL SIZER
TORNIER, INC.
CSI-TS9
In Commercial Distribution

  • 00846832014248 ()

  • Size 9 mm
CSI-TS9

  • Surgical implant template, reusable

NexFix™ - 00846832007318

No Description
TORNIER, INC.
NCS-4026
In Commercial Distribution

  • 00846832007318 ()

  • Thickness 9 mm
  • Outer Diameter: 4.5 Millimeter
  • Length: 26 Millimeter
NCS-4026

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Tornier Perform Humeral System - 00846832086290

Fracture Rasp Extension
TORNIER, INC.
IFX509
In Commercial Distribution

  • 00846832086290 ()

  • Size: 9S/9
  • Length: 210 Millimeter
IFX509

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Tornier Perform Humeral System - 00846832086214

Fracture Rasp Extension
TORNIER, INC.
IFX409
In Commercial Distribution

  • 00846832086214 ()

  • Length: 170 Millimeter
  • Size: 9S/9
IFX409

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Tornier Perform Humeral System - 00846832086009

Fracture Rasp
TORNIER, INC.
IFX209S
In Commercial Distribution

  • 00846832086009 ()

  • Size: 9S/9
  • Length: 130 Millimeter
IFX209S

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Tornier Perform Humeral System - 00846832085880

Fracture Stem Reamer
TORNIER, INC.
IFX09
In Commercial Distribution

  • 00846832085880 ()

  • Size: 9S/9
IFX09

  • Medullary canal orthopaedic reamer, rigid

A.L.P.S.® CLAVICLE PLATING SYSTEMDISTAL SUPERIOR PLATE NARROW RIGHT - 00880304834132

No Description
Biomet Orthopedics, LLC
133513055
In Commercial Distribution

  • 00880304834132 ()

  • 9 HOLE 55MM
133513055

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Persona® - 00880304810174

No Description
Zimmer, Inc.
42-5099-035-09
In Commercial Distribution

  • 00880304810174 ()

  • 9 mm Thickness
42-5099-035-09

  • Orthopaedic prosthesis implantation positioning instrument, reusable

A.L.P.S.® CLAVICLE PLATING SYSTEMDISTAL SUPERIOR PLATE NARROW LEFT - 00880304834200

No Description
Biomet Orthopedics, LLC
133523055
In Commercial Distribution

  • 00880304834200 ()

  • 9 HOLE 55MM
133523055

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

A.L.P.S.® CLAVICLE PLATING SYSTEMANTERIOR PLATE - 00880304834095

No Description
Biomet Orthopedics, LLC
133504100
In Commercial Distribution

  • 00880304834095 ()

  • 9 HOLE 100MM
133504100

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Persona® - 00880304809130

No Description
Zimmer, Inc.
42-5399-035-09
In Commercial Distribution

  • 00880304809130 ()

  • 9 mm Thickness
42-5399-035-09

  • Orthopaedic prosthesis implantation positioning instrument, reusable

ECHO BI-METRIC MICROPLASTY HIP STEM - 00880304698215

No Description
Biomet Orthopedics, LLC
110025575
In Commercial Distribution

  • 00880304698215 ()

  • SIZE 9 99MM
110025575

  • Femoral stem prosthesis trial

OSS™ Orthopedic Salvage System - 00880304554672

No Description
Biomet Orthopedics, LLC
161080
In Commercial Distribution

  • 00880304554672 ()

  • 9 cm Resection
161080

  • Coated knee tibia prosthesis

OSS™ Orthopedic Salvage System - 00880304239647

No Description
Biomet Orthopedics, LLC
150443
In Commercial Distribution

  • 00880304239647 ()

  • 9 cm Resection
150443

  • Coated knee tibia prosthesis

INTEGRA® - 00650551036678

TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, 2-STAGE, INTERNAL PORT
PMT CORPORATION
3614ES-156-2I
In Commercial Distribution

  • 00650551036678 ()

  • Width: 7.5 Centimeter
  • Length: 20 Centimeter
  • Total Volume: 1050 Centiliter
  • Projection 9 Centimeter
3614ES-156-2I

  • Skin-port tissue expander

INTEGRA® - 00650551036661

TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, 2-STAGE
PMT CORPORATION
3614ES-156-2
In Commercial Distribution

  • 00650551036661 ()

  • Projection 9 Centimeter
  • Total Volume: 1050 Centiliter
  • Length: 20 Centimeter
  • Width: 7.5 Centimeter
3614ES-156-2

  • Skin-port tissue expander

INTEGRA® - 00650551035541

TISSUE EXPANDER, CURVE, SMOOTH, 2-STAGE, INTERNAL PORT
PMT CORPORATION
3614-156-2I
In Commercial Distribution

  • 00650551035541 ()

  • Width: 7.5 Centimeter
  • Length: 20 Centimeter
  • Total Volume: 1050 Centiliter
  • Projection 9 Centimeter
3614-156-2I

  • Skin-port tissue expander

INTEGRA® - 00650551035534

TISSUE EXPANDER, CURVE, SMOOTH, 2-STAGE
PMT CORPORATION
3614-156-2
In Commercial Distribution

  • 00650551035534 ()

  • Projection 9 Centimeter
  • Total Volume: 1050 Centiliter
  • Length: 20 Centimeter
  • Width: 7.5 Centimeter
3614-156-2

  • Skin-port tissue expander

INTEGRA® - 00650551034933

BREAST EXPANDER, ANATOMICAL TEARDROP, ENHANCED TEXTURED SURFACE, INTERNAL PORT, SUTURE TABS
PMT CORPORATION
3612ES-63A-I-ST
In Commercial Distribution

  • 00650551034933 ()

  • Width: 12.5 Centimeter
  • Length: 13.5 Centimeter
  • Total Volume: 650 Centiliter
  • Projection 9 Centimeter
3612ES-63A-I-ST

  • Skin-port tissue expander

INTEGRA® - 00650551034926

BREAST EXPANDER, ANATOMICAL TEARDROP, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT, SUTURE TABS
PMT CORPORATION
3612ES-63A-IR-ST
In Commercial Distribution

  • 00650551034926 ()

  • Projection 9 Centimeter
  • Total Volume: 650 Centiliter
  • Length: 13.5 Centimeter
  • Width: 12.5 Centimeter
3612ES-63A-IR-ST

  • Skin-port tissue expander

INTEGRA® - 00650551034919

BREAST EXPANDER, ANATOMICAL TEARDROP, ENHANCED TEXTURED SURFACE, INTERNAL PORT
PMT CORPORATION
3612ES-63A-I
In Commercial Distribution

  • 00650551034919 ()

  • Width: 12.5 Centimeter
  • Length: 13.5 Centimeter
  • Total Volume: 650 Centiliter
  • Projection 9 Centimeter
3612ES-63A-I

  • Skin-port tissue expander

INTEGRA® - 00650551034902

BREAST EXPANDER, ANATOMICAL TEARDROP, ENHANCED TEXTURED SURFACE
PMT CORPORATION
3612ES-63A
In Commercial Distribution

  • 00650551034902 ()

  • Projection 9 Centimeter
  • Total Volume: 650 Centiliter
  • Length: 13.5 Centimeter
  • Width: 12.5 Centimeter
3612ES-63A

  • Skin-port tissue expander

INTEGRA® - 00650551033974

BREAST EXPANDER, ANATOMICAL TEARDROP, SMOOTH, INTERNAL PORT, SUTURE TABS
PMT CORPORATION
3612-63A-I-ST
In Commercial Distribution

  • 00650551033974 ()

  • Width: 12.5 Centimeter
  • Length: 13.5 Centimeter
  • Total Volume: 650 Centiliter
  • Projection 9 Centimeter
3612-63A-I-ST

  • Skin-port tissue expander

INTEGRA® - 00650551033967

BREAST EXPANDER, ANATOMICAL TEARDROP, SMOOTH, INTERNAL RESEAL PORT, SUTURE TABS
PMT CORPORATION
3612-63A-IR-ST
In Commercial Distribution

  • 00650551033967 ()

  • Projection 9 Centimeter
  • Total Volume: 650 Centiliter
  • Length: 13.5 Centimeter
  • Width: 12.5 Centimeter
3612-63A-IR-ST

  • Skin-port tissue expander

INTEGRA® - 00650551033950

BREAST EXPANDER, ANATOMICAL TEARDROP, SMOOTH, INTERNAL PORT
PMT CORPORATION
3612-63A-I
In Commercial Distribution

  • 00650551033950 ()

  • Width: 12.5 Centimeter
  • Length: 13.5 Centimeter
  • Total Volume: 650 Centiliter
  • Projection 9 Centimeter
3612-63A-I

  • Skin-port tissue expander

INTEGRA® - 00650551033943

BREAST EXPANDER, ANATOMICAL TEARDROP, SMOOTH
PMT CORPORATION
3612-63A
In Commercial Distribution

  • 00650551033943 ()

  • Projection 9 Centimeter
  • Total Volume: 650 Centiliter
  • Length: 13.5 Centimeter
  • Width: 12.5 Centimeter
3612-63A

  • Skin-port tissue expander

OSS(TM) - 00880304346956

No Description
Biomet Orthopedics, LLC
32-472073
In Commercial Distribution

  • 00880304346956 ()

  • 9 CM RESECTION
32-472073

  • Knee tibia prosthesis trial, reusable

COMPOSITCP MODULAR DRIVER - 00880304484955

No Description
Biomet Orthopedics, LLC
905274
In Commercial Distribution

  • 00880304484955 ()

  • 9 - 10 - 11MM
905274

  • Surgical screwdriver, reusable

Universal Tibial Nail, Solid - 06902139071521

No Description
Double Medical Technology Inc.
070050360
In Commercial Distribution

  • 06902139071521 ()

  • Length: 360 Millimeter
  • Diameter: 9 Milimeter
070050360

  • Tibia intramedullary nail

SHEEHAN OSTEOTOME - 00192896030992

SHEEHAN OSTEOTOME
SONTEC INSTRUMENTS, INC.
330-889
In Commercial Distribution

  • 00192896030992 ()

  • 9 Millimeter Tip
  • Length: 6.25 Inch
330-889

  • Orthopaedic osteotome handle

COTTLE OSTEOTOME - 00192896030909

COTTLE PLASTIC OSTEOTOME WITH END STOP PLATFORM SPECIAL HEAVY EDGE NO CORNER BLADES
SONTEC INSTRUMENTS, INC.
330-849D
In Commercial Distribution

  • 00192896030909 ()

  • Length: 7 Inch
  • 9 Millimeter Tip
330-849D

  • Orthopaedic osteotome

TWO HANDED CURETTE - 00192896028333

TWO HANDED CURETTE STRAIGHT OVAL CUP PHENOLIC HANDLE SIZE 4
SONTEC INSTRUMENTS, INC.
320-644
In Commercial Distribution

  • 00192896028333 ()

  • Length: 15 Inch
  • 9 Inch Handle
320-644

  • Bone curette, reusable

TWO HANDED CURETTE - 00192896028159

TWO HANDED CURETTE STRAIGHT CONE RING BLACK HANDLE
SONTEC INSTRUMENTS, INC.
320-615B
In Commercial Distribution

  • 00192896028159 ()

  • Length: 14.5 Inch
  • 9 Millimeter Tip
320-615B

  • Bone curette, reusable

TWO HANDED CURETTE - 00192896028142

TWO HANDED CURETTE STRAIGHT CONE RING PHEONLIC HANDLE
SONTEC INSTRUMENTS, INC.
320-615
In Commercial Distribution

  • 00192896028142 ()

  • Length: 14.5 Inch
  • 9 Millimeter Tip
320-615

  • Bone curette, reusable

Micro Bayonet Vannas Scissors - 00192896103566

Micro Bayonet Vannas Scissors Round Handle Curved
SONTEC INSTRUMENTS, INC.
400-125
In Commercial Distribution

  • 00192896103566 ()

  • Length: 8.25 Inch
  • Blade 9 Millimeters


  • General-purpose surgical scissors, reusable

Micro Bayonet Vannas Scissors - 00192896103559

Micro Bayonet Vannas Scissors Round Handle Straight
SONTEC INSTRUMENTS, INC.
400-124
In Commercial Distribution

  • 00192896103559 ()

  • Length: 8.25 Inch
  • Blade 9 Millimeters


  • General-purpose surgical scissors, reusable

CURETTE - 00192896092365

CURETTE STRAIGHT OVAL CUP SIZE 1 PHONELIC HANDLE
SONTEC INSTRUMENTS, INC.
320-641
In Commercial Distribution

  • 00192896092365 ()

  • 9 Inches Handle
  • Length: 15 Inch
320-641

  • Bone curette, reusable

CURETTE - 00192896092358

CURETTE STRAIGHT OVAL CUP SIZE 0 PHONELIC HANDLE
SONTEC INSTRUMENTS, INC.
320-640
In Commercial Distribution

  • 00192896092358 ()

  • 9 Inches Handle
  • Length: 15 Inch
320-640

  • Bone curette, reusable

COTTLE ELEVATOR - 00192896035775

COTTLE ELEVATOR SLIGHTLY CURVED TIP
SONTEC INSTRUMENTS, INC.
412-527
In Commercial Distribution

  • 00192896035775 ()

  • Length: 7.5 Inch
  • 9 Millimeter Tip
412-527

  • Periosteal elevator, reusable
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