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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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Trigon - 00810005669405

Instrument: CC Wedge 10mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-2510T-CC
In Commercial Distribution

  • 00810005669405 ()

  • 10mm, Thick
  • Width: 25 Millimeter


  • Orthopaedic inorganic implant inserter/extractor, reusable

Trigon - 00810005669399

Instrument: CC Wedge 8mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-2508T-CC
In Commercial Distribution

  • 00810005669399 ()

  • 8mm, Thick
  • Width: 25 Millimeter


  • Orthopaedic inorganic implant inserter/extractor, reusable

Trigon - 00810005669382

Instrument: Trigon CC Wedge Graft Packing Block. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-1000T-CGPB
In Commercial Distribution

  • 00810005669382 ()


  • Surgical tissue compression device

CD197-PE - 04049934134258

REA108 recognizes human CD197 which is a chemokine receptor with a C-C motif that mediates homing of T cells to secondary lymphoid organs via high endothelial venules (HEV) and is also known as CCR7. For example, naive T cells migrate very efficiently through lymph nodes using the adhesion molecules L-selectin, CD62L, and CCR7. Ligands for CCR7, e.g. CCL19, are expressed by the HEV of secondary lymphoid organs, by parenchymal cells within T cell zones of lymph nodes, and by endothelial cells at the openings of lymphatic vessels within peripheral tissues. Expression of CCR7 and the CD45RA isoform distinguishes three subsets of T cells: naive T cells (CCR7+CD45RA+), central memory T cells (CCR7+ CD45RA-), and effector memory T cells (CCR7- CD45RA-).
Miltenyi Biotec B.V. & Co. KG
170-081-034
In Commercial Distribution

  • 04049934134258 ()


  • Assay development analyte-specific reagent IVD

CD197-VioBlue - 04049934133763

REA546 recognizes the human CD197 antigen, which is also known as CCR7. CD197 is a chemokine receptor with a C-C motif that mediates homing of T cells to secondary lymphoid organs via high endothelial venules (HEV). For example, naive T cells migrate very efficiently through lymph nodes using the adhesion molecules L-selectin, CD62L, and CCR7. Ligands for CCR7, e.g. CCL19, are expressed by the HEV of secondary lymphoid organs, by parenchymal cells within T cell zones of lymph nodes, and by endothelial cells at the openings of lymphatic vessels within peripheral tissues. Expression of CCR7 and the CD45RA isoform distinguishes three subsets of T cells: naive T cells (CCR7+CD45RA+), central memory T cells (CCR7+ CD45RA-), and effector memory T cells (CCR7- CD45RA-). Additional information: Clone REA546 displays negligible binding to Fc receptors.
Miltenyi Biotec B.V. & Co. KG
170-081-083
In Commercial Distribution

  • 04049934133763 ()


  • Assay development analyte-specific reagent IVD

Angios Classic Angiographic Convenience Kit - 00885672101510

Angiographic Convenience Kit, 6F
Oscor Inc.
ANG4-0241
In Commercial Distribution

  • 00885672101510 ()

  • JL 4.0/110 cm, JR 4.0/110 cm, Straight Pigtail/120 cm
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Maximum Recommended Guidewire 0.038 in
  • Recommended Pressure Limit: 1200 psi max.
  • Adelante Sigma Introducer, 6F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Pigtail Side Holes: 5
  • Flow Rate: JR: 32 mL/sec, JL: 32 mL/sec, PT: 35 mL/sec
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
ANG4-0241

  • Angiographic catheter, single-use

Angios Classic Angiographic Convenience Kit - 00885672101473

Angiographic Convenience Kit, 6F
Oscor Inc.
ANG4-0042
In Commercial Distribution

  • 00885672101473 ()

  • JL 4.0/100 cm, JR 4.0/100 cm, Pigtail 145°/110 cm
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Pigtail Side Holes: 5
  • Maximum Recommended Guidewire 0.038 in
  • Recommended Pressure Limit: 1200 psi max.
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Adelante Sigma Introducer, 6F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Flow Rate: JR: 33 mL/sec, JL: 34 mL/sec, PT: 34 mL/sec
ANG4-0042

  • Angiographic catheter, single-use

Angios Classic Angiographic Convenience Kit - 00885672008734

Angiographic Convenience Kit, 6F
Oscor Inc.
ETANG4-0342
Not in Commercial Distribution

  • 00885672008734 ()

  • Flow Rate: JR: 33 mL/sec, JL: 34 mL/sec, PT: 34 mL/sec
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Maximum Recommended Guidewire 0.038 in
  • Pigtail Side Holes: 5
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Adelante Sigma Introducer, 6F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Recommended Pressure Limit: 1200 psi max.
  • JL 4.0/100 cm, JR 4.0/100 cm, Pigtail 145°/110 cm
ETANG4-0342

  • Angiographic catheter, single-use

Angios Classic Angiographic Convenience Kit - 00885672101480

Angiographic Convenience Kit, 6F
Oscor Inc.
ANG4-0041
In Commercial Distribution

  • 00885672101480 ()

  • Maximum Recommended Guidewire 0.038 in
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Recommended Pressure Limit: 1200 psi max.
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Pigtail Side Holes: 5
  • JL 4.0/100 cm, JR 4.0/100 cm, Straight Pigtail/110 cm
  • Flow Rate: JR: 33 mL/sec, JL: 34 mL/sec, PT: 36 mL/sec
  • Adelante Sigma Introducer, 6F, Length: 10 cm, Needle 18 G, Syringe 10 cc
ANG4-0041

  • Angiographic catheter, single-use

Angios Classic Angiographic Convenience Kit - 00885672103392

Angiographic Convenience Kit, 6F
Oscor Inc.
ANG4-0442
In Commercial Distribution

  • 00885672103392 ()

  • Flow Rate: JR: 32 mL/sec, JL: 29 mL/sec, PT: 33 mL/sec
  • Recommended Pressure Limit: 1200 psi max.
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Adelante Sigma Introducer, 6F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • JL 4.0/120 cm, JR 4.0/120 cm, Pigtail 145°/120 cm
  • Pigtail Side Holes: 5
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Maximum Recommended Guidewire 0.038 in
ANG4-0442

  • Angiographic catheter, single-use
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