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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 Stem Impactor The Modular Ulnar Head stem impactor impacts the stem into selected head placed in the back table assembly.
Ascension Orthopedics, Inc.
IMP60000
In Commercial Distribution

  • M269IMP600001 ()
  • 10381780245766 ()

  • .313 in inner head dia
IMP-600-00

  • Orthopaedic implant impactor, reusable
Titan™ Reverse Shoulder System The handle is used to remove glenospheres.
Ascension Orthopedics, Inc.
HDL096006701
In Commercial Distribution

  • M269HDL0960067011 ()
  • 10381780245476 ()

  • 10.4 in x .255in diameter
HDL-0960-067-01

  • Surgical instrument handle, non-torque-limiting
Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
CTD90003
In Commercial Distribution

  • M269CTD900031 ()
  • 10381780244301 ()

  • Size 3; .456 in W
CTD-900-03

  • Cannulated surgical drill bit, single-use
Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
CTD90002
In Commercial Distribution

  • M269CTD900021 ()
  • 10381780244295 ()

  • Size 2; .406 in W
CTD-900-02

  • Cannulated surgical drill bit, single-use
Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
CTD90001
In Commercial Distribution

  • M269CTD900011 ()
  • 10381780244288 ()

  • Size 1; .356 in W
CTD-900-01

  • Cannulated surgical drill bit, single-use
Total Shoulder System Central Starter Drill Bushing
Ascension Orthopedics, Inc.
BH0920048002
In Commercial Distribution

  • M269BSH09230480021 ()
  • 10381780242727 ()

  • Size M-L; 1.19 in H
BSH-0920-048-002

  • Bone-resection orthopaedic reamer, reusable
TSS Pin Bushing, 2.5 XS-S
Ascension Orthopedics, Inc.
BSH-0923-048-001
In Commercial Distribution

  • M269BSH09230480011 ()
  • 10381780242710 ()

  • Size XS-S; 1.14 in H
BSH-0923-048-001

  • Bone-resection orthopaedic reamer, reusable
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
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