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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® First Choice® DRUJ System MUH Reamer Sz. 6.5 The Modular Ulnar Head Reamer compresses and/or removes bone in the ulnar medullary canal to create the proper shape and size for implant accommodation.
Ascension Orthopedics, Inc.
BRH-600-S65
In Commercial Distribution

  • M269BRH600651 ()
  • 10381780242673 ()

  • .259 in dia; Size 6.5
BRH-600-S65

  • Bone-resection orthopaedic reamer, reusable
Integra® First Choice® DRUJ System MUH Reamer Sz. 5.5 The Modular Ulnar Head Reamer compresses and/or removes bone in the ulnar medullary canal to create the proper shape and size for implant accommodation.
Ascension Orthopedics, Inc.
BRH-600-S55
In Commercial Distribution

  • M269BRH600551 ()
  • 10381780242666 ()

  • .220 in dia; Size 5.5
BRH-600-S55

  • Bone-resection orthopaedic reamer, reusable
Integra® First Choice® DRUJ System MUH Reamer Sz. 4.5 The Modular Ulnar Head Reamer compresses and/or removes bone in the ulnar medullary canal to create the proper shape and size for implant accommodation.
Ascension Orthopedics, Inc.
BRH-600-S45
In Commercial Distribution

  • M269BRH600451 ()
  • 10381780242659 ()

  • .180 in dia; Size 4.5
BRH-600-S45

  • Bone-resection orthopaedic reamer, reusable
Integra® First Choice® DRUJ System MUH Reamer Sz. 3.5 The Modular Ulnar Head Reamer compresses and/or removes bone in the ulnar medullary canal to create the proper shape and size for implant accommodation.
Ascension Orthopedics, Inc.
BRH-600-S35
In Commercial Distribution

  • M269BRH600351 ()
  • 10381780242642 ()

  • .141 in dia; Size 3.5
BRH-600-S35

  • Bone-resection orthopaedic reamer, reusable
Modular Radial Head Broach, MRH, Sz. 04
Ascension Orthopedics, Inc.
BRH35004
In Commercial Distribution

  • M269BRH350041 ()
  • 10381780242420 ()

  • .301 in dia; Size 04
BRH-350-04

  • Orthopaedic broach
Modular Radial Head Radial Head Broach Size 24
Ascension Orthopedics, Inc.
BRH30024
In Commercial Distribution

  • M269BRH300241 ()
  • 10381780242413 ()

  • .361 in dia; Size 24
BRH-300-24

  • Orthopaedic broach
Modular Radial Head Radial Head Broach Size 22
Ascension Orthopedics, Inc.
BRH30022
In Commercial Distribution

  • M269BRH300221 ()
  • 10381780242406 ()

  • .331 in dia; Size 22
BRH-300-22

  • Orthopaedic broach
Modular Radial Head Radial Head Broach Size 20
Ascension Orthopedics, Inc.
BRH30020
In Commercial Distribution

  • M269BRH300201 ()
  • 10381780242390 ()

  • .301 in dia; Size 20
BRH-300-20

  • Orthopaedic broach
Rod Connector is a part of the Tibial Alignment guide, and is used to connect the Tibial Rod to the Proximal Translation Block for proper positioning to the center of the patients distal tibial metaphysis.
Ascension Orthopedics, Inc.
10203005
In Commercial Distribution

  • M268102030051 ()
  • 10381780240143 ()

  • 1.7 in Lx .709in diameter
10203005

  • Joint prosthesis implantation kit, reusable
Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
SZR9005621
In Commercial Distribution

  • M269SZR90056211 ()
  • 10381780237341 ()

  • Size 56-21; 2.205 in dia
SZR-900-56-21

  • Surgical implant template, reusable
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