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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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Arcos® Modular Revision Hip System - 00880304474352

No Description
Biomet Orthopedics, LLC
11-302124
In Commercial Distribution

  • 00880304474352 ()

  • 24 MM
11-302124

  • Coated femoral stem prosthesis, modular

RINGLOC(R) ACETABULAR IMPACTOR PLATE - 00880304371156

No Description
Biomet Orthopedics, LLC
423334
In Commercial Distribution

  • 00880304371156 ()

  • SIZE 24
423334

  • Orthopaedic implant impactor, reusable

RINGLOC + HIP SYSTEM - 00880304455078

No Description
Biomet Orthopedics, LLC
106024
In Commercial Distribution

  • 00880304455078 ()

  • 24 SIZE
106024

  • Acetabular shell

Compress Device - 00880304461642

No Description
Biomet Orthopedics, LLC
178566
In Commercial Distribution

  • 00880304461642 ()

  • 24 MM
178566

  • Knee femur stem prosthesis

ARCOS MODULAR REVISION SYSTEM - 00880304496873

No Description
Biomet Orthopedics, LLC
31-300574
In Commercial Distribution

  • 00880304496873 ()

  • SIZE 24
31-300574

  • Bone-resection orthopaedic reamer, reusable

PEANUT PLATING SYSTEM - 00880304492530

No Description
Biomet Orthopedics, LLC
24524
In Commercial Distribution

  • 00880304492530 ()

  • 24 MM
24524

  • Orthopaedic bone screw, non-bioabsorbable, sterile

MEDALLION MODULAR HIP SYSTEM - 00880304640047

No Description
Biomet Orthopedics, LLC
71-007001
In Commercial Distribution

  • 00880304640047 ()

  • 24 MM
71-007001

  • Uncoated hip femur prosthesis, modular

GenetiSure Dx Hybridization Kit - 05700571112625

GenetiSure Dx Hybridization Kit
AGILENT TECHNOLOGIES, INC.
K1201-64200
In Commercial Distribution

  • 05700571112625 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)

GenetiSure Dx Labeling Kit Purification Columns - 05700571112618

GenetiSure Dx Labeling Kit Purification Columns
AGILENT TECHNOLOGIES, INC.
K1201-64110
In Commercial Distribution

  • 05700571112618 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)

GenetiSure Dx Labeling Kit - 05700571112601

GenetiSure Dx Labeling Kit
AGILENT TECHNOLOGIES, INC.
K1201-64105
In Commercial Distribution

  • 05700571112601 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)

GenetiSure Dx Postnatal Assay - 05700571108697

GenetiSure Dx Postnatal Assay
AGILENT TECHNOLOGIES, INC.
K1201A
In Commercial Distribution

  • 05700571108697 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)

Sierra™ - 10889910059141

S2S CrossBar, 24 - 29mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-2021
Not in Commercial Distribution

  • 10889910059141 ()

  • 24 - 29mm
50-2021

  • Vertebral body prosthesis, non-sterile

RIM-LOC HIP SYSTEM - 00880304191655

No Description
Biomet Orthopedics, LLC
105424
In Commercial Distribution

  • 00880304191655 ()

  • 24 SIZE
105424

  • Acetabular shell

INSERTER PLATE W/POST - 00880304009288

No Description
Biomet Orthopedics, LLC
423694
In Commercial Distribution

  • 00880304009288 ()

  • 24 MM
423694

  • Orthopaedic inorganic implant inserter/extractor, reusable

Alexis Wound Protector-Retractor - 00607915132958

Wound Retractor and Protector
APPLIED MEDICAL RESOURCES CORPORATION
C8322
In Commercial Distribution

  • 10607915132955 ()
  • 00607915132958 ()

  • 2-4 cm


  • Radial surgical retractor

Alexis Wound Protector-Retractor - 00607915117245

Wound Retractor and Protector
APPLIED MEDICAL RESOURCES CORPORATION
C8312
In Commercial Distribution

  • 10607915117242 ()
  • 00607915117245 ()

  • 2-4 cm


  • Radial surgical retractor

INTROCAN SAFETY® - 04046963318314

Introcan Safety® IV Catheter 24 Ga. x 0.75 in., FEP, Winged
B. BRAUN MEDICAL INC.
4254503-02
In Commercial Distribution

  • 04046963318048 ()
  • 04046963318314 ()
  • 04046963317706 ()

  • Catheter-Gauge : 24
4254503-02

  • Peripheral vascular intervention infusion catheter

INTROCAN SAFETY® - 04046963188559

Introcan Safety® IV Catheter 24 Ga. x 0.55 in., PUR, Straight
B. BRAUN MEDICAL INC.
4251607-02
In Commercial Distribution

  • 04046963188566 ()
  • 04046963188559 ()
  • 04046963188535 ()

  • Catheter-Gauge : 24
4251607-02

  • Peripheral vascular intervention infusion catheter

INTROCAN SAFETY® 3 - 04046964013997

Introcan Safety® 3 Closed IV Catheter 24 Ga. x 0.75 in., PUR, Winged
B. BRAUN MEDICAL INC.
4251127-02
In Commercial Distribution

  • 04046964163036 ()
  • 04046964013997 ()
  • 04046963963460 ()

  • Catheter-Gauge : 24
4251127-02

  • Peripheral vascular intervention infusion catheter

INTROCAN SAFETY® - 04046963358679

Introcan Safety® IV Catheter 24 Ga. x 0.55 in., FEP, Straight, Thinwall
B. BRAUN MEDICAL INC.
4251612-02
Not in Commercial Distribution

  • 04046963358686 ()
  • 04046963358679 ()
  • 04046963326340 ()

  • Catheter-Gauge : 24
4251612-02

  • Peripheral vascular intervention infusion catheter
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