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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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Integra® - 10381780246374

PyroCarbon PIP Total Joint PIP Vertical Cut Guide
Ascension Orthopedics, Inc.
OSG20000
In Commercial Distribution

  • M269OSG200001 ()
  • 10381780246374 ()

  • 2.39 in L
OSG-200-00

  • Custom-made orthopaedic/craniofacial surgical guide

Ascension® - 10381780246367

Ascension® MCP Osteotomy Guide, Proximal
Ascension Orthopedics, Inc.
OSG10000P
In Commercial Distribution

  • M269OSG10000P1 ()
  • 10381780246367 ()

  • 2.04 in L
OSG-100-00P

  • Orthopaedic reamer guide

Ascension® - 10381780246350

Ascension® MCP Osteotomy Guide, Distal
Ascension Orthopedics, Inc.
OSG10000D
In Commercial Distribution

  • M269OSG10000D1 ()
  • 10381780246350 ()

  • 2.48 in L
OSG-100-00D

  • Orthopaedic reamer guide

MemoFix® Super Elastic Nitinol Staple System - 10381780246251

Integra® MemoFix® Staple System The MemoFix removal tool is used to remove staples by lifting the staple bridge to a position in which the staple spreader can be engaged.
Ascension Orthopedics, Inc.
MS-2940
In Commercial Distribution

  • M269MS29401 ()
  • 10381780246251 ()

  • 3.5 in L
MS-2940

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra® - 10381780245308

Integra®Surgical Instruments The Guide Pin is used in conjunction with the cup and cone reamers.
Ascension Orthopedics, Inc.
GDW-895-00
In Commercial Distribution

  • M269GDW895001 ()
  • 10381780245308 ()

  • 6.0 in L
GDW-895-00

  • Orthopaedic guidewire, reusable

Titan™ - 10381780245278

Titan™ Total Shoulder System The head cutting depth gauge can be used to assess the cutting plane.
Ascension Orthopedics, Inc.
GU0920058001
In Commercial Distribution

  • M269GAU09200580011 ()
  • 10381780245278 ()

  • 5.25 in L
GAU-0920-058-001

  • Surgical depth gauge, reusable

Integra® - 10381780245261

Integra®Surgical Instruments The torque limiter is used during assembly and implantation of devices.
Ascension Orthopedics, Inc.
G207153
In Commercial Distribution

  • M269G2071531 ()
  • 10381780245261 ()

  • 4.52 in L
G207153

  • Surgical instrument torque limiter

Integra®Ti6® - 10381780244950

Integra® Ti6® The screw removal tool is used in conjunction with the Integra Ti6 Screw system.
Ascension Orthopedics, Inc.
FS1040
In Commercial Distribution

  • M269FS10401 ()
  • 10381780244950 ()

  • 5.4 in L
FS1040

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra® Ti6® - 10381780244899

The titanium swivel driver handle is useful for inserting small screws.
Ascension Orthopedics, Inc.
FS1005
In Commercial Distribution

  • M269FS10051 ()
  • 10381780244899 ()

  • 4.08 in L
FS1005

  • Surgical instrument handle, non-torque-limiting

Construct ™ - 10381780244691

Construct® Ankle Fusion Plate System The drill bit is a cutting tool used to create cylindrical holes.
Ascension Orthopedics, Inc.
DRL-5010-50
Not in Commercial Distribution

  • M269DRL5010501 ()
  • 10381780244691 ()

  • 6.72 in L
DRL501050

  • Cannulated surgical drill bit, single-use
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