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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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TORNIER, INC.
DKY061
In Commercial Distribution

  • 00846832010882 ()

  • Outer Diameter: 6.5 Millimeter
DKY061

  • Hinged total elbow prosthesis
The STROPP (Single Tunnel Repair of Plantar Plate) System is a sterile packaged kit that include PEEK implants and related instruments for plantar plate repair. Implants are packaged with the following manual surgical instruments for general use: a needle, needle passer, suture passer, an inserter, K-wires and distractor. The implants are compatible with Size 0 suture; suture is not included with the system. The STROPP System is intended for use with a suture in metatarsal ligament and tendon repairs.
CROSSROADS EXTREMITY SYSTEMS
STRoPP Plantar Plate Repair Kit - Sterile
In Commercial Distribution

  • 00815432023783 ()

  • 3.0mm Diameter x 8.0mm Length
1601-0002

  • Suturing needle, single-use
  • Suturing unit, single-use
  • Bone-resection orthopaedic reamer, single-use
  • Bone-resection orthopaedic reamer, reprocessed
  • Tendon/ligament bone anchor, non-bioabsorbable
  • Suturing needle holder, single-use
  • Orthopaedic intraoperative positioning pin, single-use
LimFlow Conical Stent Graft (4.0-5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-40060-US-21
In Commercial Distribution

  • 00850041730110 ()


  • Arteriovenous endovascular stent-graft
LimFlow Conical Stent Graft (3.5-5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-35060-US-21
In Commercial Distribution

  • 00850041730097 ()


  • Arteriovenous endovascular stent-graft
LimFlow Extension stent graft (5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-55060-US-21
In Commercial Distribution

  • 00850041730073 ()


  • Arteriovenous endovascular stent-graft
LimFlow Extension Stent Graft (5.5 mm x 100 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-55100-US-21
In Commercial Distribution

  • 00850041730059 ()


  • Arteriovenous endovascular stent-graft
LimFlow Extension Stent Graft (5.5 mm x 150 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-55150-US-21
In Commercial Distribution

  • 00850041730042 ()


  • Arteriovenous endovascular stent-graft
LimFlow Extension Stent Graft (5.5 mm x 200 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-55200-US-21
In Commercial Distribution

  • 00850041730035 ()


  • Arteriovenous endovascular stent-graft
The marked Straight Ventricular Catheter (inner diameter 1.4mm, outer diameter 2.7mm) features radiopaque length markings at 2.0 cm intervals from the tip. It is provided with an introducer. A straight connector and a silicone right angle guide, are supplied as accessories.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
9MD102B
Not in Commercial Distribution

  • 10381780035695 ()
  • M2729MD102B1 ()

  • Straight Venth. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
9MD102B

  • Intracerebral infusion/drainage catheter, long-term
Compression Lag Screw, 15mm Sliding, 115 120mm
TDM Co., Ltd.
508-41120
In Commercial Distribution

  • 08800043912153 ()
508-41120

  • Femoral neck fixation sliding bone screw
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