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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® Total Foot System The forceps are used to hold plates and screws in conjunction with the Integra Total Foot System.
Ascension Orthopedics, Inc.
503 004250
Not in Commercial Distribution

  • M2695030042501 ()
  • 10381780241591 ()

  • NA
503 004250

  • Surgical implant handling forceps
Integra® Total Foot System The forceps are used to hold plates and screws in conjunction with the Integra Total Foot System.
Ascension Orthopedics, Inc.
2204250
In Commercial Distribution

  • M26922042501 ()
  • 10381780241454 ()

  • 142.5mm L x 14mm W opening
2204250

  • Surgical implant handling forceps
CAPTURE™ High Torque Screw System The quick connect ratchet t-handle is used in conjunction with the Capture High Torque Screw system.
Ascension Orthopedics, Inc.
TR41800-J-004
In Commercial Distribution

  • M269TR41800J0041 ()
  • 10381780247722 ()

  • NA
TR41800-J-004

  • Surgical instrument handle, non-torque-limiting
CAPTURE™ High Torque Screw System The tissue protector is used during guide pin placement in the Capture high torque screw system.
Ascension Orthopedics, Inc.
TPR-5000-506-070
In Commercial Distribution

  • M269TPR50005060701 ()
  • 10381780247708 ()

  • 80.09 mm L with 124.46 mm L handle
PR5000506070

  • Surgical drill guide, reusable
Integra® Ti6® The 3-prong driver shaft is used to create holes in conjunction with the Ti6 TQ-series quick snap screws.
Ascension Orthopedics, Inc.
FS5010
In Commercial Distribution

  • M269FS50101 ()
  • 10381780245223 ()

  • 3.13in L x .146in Diameter
FS5010

  • Cannulated surgical drill bit, single-use
Integra® Ti6® The cannulated driver shaft is used to create holes in conjunction with the Ti6 TC-series 3.0/4.0mm screws.
Ascension Orthopedics, Inc.
FS3020
In Commercial Distribution

  • M269FS30201 ()
  • 10381780245131 ()

  • 112 mm L x 4.06 mm dia
FS3020

  • Surgical screwdriver, reusable
Integra® Ti6® The cannulated driver shaft is used to create holes in conjunction with the Ti6 TC-series 2.0/2.5mm screws.
Ascension Orthopedics, Inc.
FS3010
In Commercial Distribution

  • M269FS30101 ()
  • 10381780245124 ()

  • 88 mm L x 2.67 mm dia
FS3010

  • Surgical screwdriver, reusable
Integra® External Fixation System The pivoting socket wrench is used to tighten nuts and other parts in the external fixation system.
Ascension Orthopedics, Inc.
12224506
In Commercial Distribution

  • M269122245061 ()
  • 10381780248088 ()

  • 157.8 mm L; 10.03 mm opening
12224506

  • External orthopaedic fixation system, reusable
Integra® Ti6® The Bone Reduction Forceps are used to hold objects in the Integra Ti6 system. These forceps are serrated.
Ascension Orthopedics, Inc.
FS1012
In Commercial Distribution

  • M269FS10121 ()
  • 10381780244929 ()

  • NA
FS1012

  • Surgical implant handling forceps
Ready-to-Use, high sensitivity 2-step detection system designed for detection of specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method.
BIO SB, INC.
50 ml each
In Commercial Distribution

  • B502BSB00040 ()
BSB 0004

  • Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry
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