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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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Symmetry Surgical® - 00887482144398

Tray, Sterilization, 15 in x 10 1/2 in x 3 1/2 in
SYMMETRY SURGICAL INC.
20-1015
Not in Commercial Distribution

  • 00887482144398 ()
20-1015

  • Instrument tray, reusable

Symmetry Surgical® - 00887482144374

Tray, Sterilization, 10 in x 6 1/2 in x 2 1/2 in
SYMMETRY SURGICAL INC.
20-1006X
Not in Commercial Distribution

  • 00887482144374 ()
20-1006X

  • Instrument tray, reusable

Integra® - 10381780246442

PyroCarbon PIP Total Joint PIP Proximal Cut Guide, Sz. 40
Ascension Orthopedics, Inc.
OSG20040P
In Commercial Distribution

  • M269OSG20040P1 ()
  • 10381780246442 ()

  • Size 40; 1.250 in L x .966 in outer W x .27 in inner W
OSG-200-40P

  • Custom-made orthopaedic/craniofacial surgical guide

Integra® - 10381780246428

PyroCarbon PIP Total Joint PIP Proximal Cut Guide, Sz. 30
Ascension Orthopedics, Inc.
OSG20030P
In Commercial Distribution

  • M269OSG20030P1 ()
  • 10381780246428 ()

  • Size 30; 1.250 in L x .926 in outer W x .25 in inner W
OSG-200-30P

  • Custom-made orthopaedic/craniofacial surgical guide

Integra® - 10381780246404

PyroCarbon PIP Total Joint PIP Proximal Cut Guide Sz 20
Ascension Orthopedics, Inc.
OSG20020P
In Commercial Distribution

  • M269OSG20020P1 ()
  • 10381780246404 ()

  • Size 20; 1.250 in L x .879 in outer W x .23 in inner W
OSG-200-20P

  • Custom-made orthopaedic/craniofacial surgical guide

Integra® - 10381780246381

PyroCarbon PIP Total Joint PIP Proximal Cut Guide Sz 10
Ascension Orthopedics, Inc.
OSG20010P
In Commercial Distribution

  • M269OSG20010P1 ()
  • 10381780246381 ()

  • Size 10; 1.225 in L x .814 in outer W x .19 in inner W
OSG-200-10P

  • Custom-made orthopaedic/craniofacial surgical guide

Symmetry Surgical® - 00887482049860

Speculum, Sims Vaginal, Double-Ended, #1, 1 in x 2 3/4 in x 1 1/8 in x 3 in
SYMMETRY SURGICAL INC.
52-2001
Not in Commercial Distribution

  • 00887482049860 ()
52-2001

  • Vaginal speculum, reusable

Integra® - 10381780248026

Integra® External Fixation System The AO t-handle is used in conjunction with the external fixation system.
Ascension Orthopedics, Inc.
5010001000
In Commercial Distribution

  • M26950100010001 ()
  • 10381780248026 ()

  • 4.399 in L handle
5010001000

  • Surgical instrument handle, non-torque-limiting

Construct ™ - 10381780246572

Construct® Ankle Fusion Plate System The depth gauge for plate screws is a tool used to measure the required depth of a drilled hole.
Ascension Orthopedics, Inc.
PDG-5010-01
Not in Commercial Distribution

  • M269PDG5010011 ()
  • 10381780246572 ()

  • .044 in W tip
PDG501001

  • Surgical depth gauge, reusable

Integra® - 10381780245735

Modular Radial Head Impactor, Stem, MRH
Ascension Orthopedics, Inc.
IMP35000
In Commercial Distribution

  • M269IMP350001 ()
  • 10381780245735 ()

  • .375 in inner dia
IMP-350-00

  • Orthopaedic implant impactor, reusable
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