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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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Titan™ Total Shoulder System The cannulated center starter drill is used with the total shoulder system.
Ascension Orthopedics, Inc.
DL0920047001
In Commercial Distribution

  • M269DRL09200470011 ()
  • 10381780244561 ()

  • .195 in W tip
DRL-0920-047-001

  • Cannulated surgical drill bit, single-use
Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
BRH90000
In Commercial Distribution

  • M269BRH900001 ()
  • 10381780242680 ()

  • .924 in L tip
BRH-900-00

  • Orthopaedic broach
No Description
Zimmer, Inc.
SSI005235
In Commercial Distribution

  • 00889024578418 ()

  • 34mm x 12 in
SSI005235

  • Surgical screwdriver, reusable
The Head Sizing Plate is used to find the base width, along with the need for a concentric or eccentric head, prior to trialing the humeral head.
Ascension Orthopedics, Inc.
HSP-0923-070-001E
In Commercial Distribution

  • M269HSP0923070001E1 ()
  • 10381780124573 ()

  • Size38-E; 1.5 in dia
HSP-0923-070-001E

  • Surgical implant template, reusable
BECKMAN-ADSON RETRACTOR 1x1''
SURGIX MEDICAL LLC
G2N52251
In Commercial Distribution

  • 00840343720520 ()

  • Length: 1 Inch
  • Tip Size 1 in
G2N52251

  • Self-retaining surgical retractor, reusable
HIBBS RETRACTOR 3/4'' x 2-1/4'
SURGIX MEDICAL LLC
G2N52205
In Commercial Distribution

  • 00840343720513 ()

  • Length: 2.25 Inch
  • Tip Size 0.75 in
G2N52205

  • Hand-held surgical retractor, reusable
Peripheral Plaque Excision System;Large Vessel Xtended Tip with MEC TechNlogy
Covidien LP
P4055
In Commercial Distribution

  • 00821684044605 ()

  • Outer Diameter: 2.7 Millimeter
  • Length: 9.0 Centimeter
  • Catheter Gauge: 8 French
  • Compatible Guidewire,0.014,IN;
P4055

  • Mechanical atherectomy system catheter, peripheral
Peripheral Plaque Excision system;Distal Vessel Standard Tip
Covidien LP
P4028
In Commercial Distribution

  • 00821684043240 ()

  • Outer Diameter: 1.9 Millimeter
  • Length: 2.6 Centimeter
  • Catheter Gauge: 6 French
  • Compatible Guidewire,0.014,IN;
P4028

  • Mechanical atherectomy system catheter, peripheral
Peripheral Plaque Excision system;Small Vessel Xtra Long Tip
Covidien LP
P4033
In Commercial Distribution

  • 00821684043233 ()

  • Outer Diameter: 2.4 Millimeter
  • Length: 7.2 Centimeter
  • Catheter Gauge: 7 French
  • Compatible Guidewire,0.014,IN;
P4033

  • Mechanical atherectomy system catheter, peripheral
.018
Covidien LP
AB18W060020090
In Commercial Distribution

  • 00821684046425 ()

  • Wire Size:0.018 IN
  • Length: 90 Centimeter
AB18W060020090

  • Peripheral angioplasty balloon catheter, basic
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