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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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MECTRON - E322021700051010

EN3 is an endo apical debrider dental insert to be used in conjunction with Mectron Piezosurgery handpieces.
MECTRON SPA
EN3 -US
In Commercial Distribution

  • E322021700051010 ()
02170005-101

  • Dental ultrasonic surgical system handpiece tip

MECTRON - E322021700011010

EN1 is a Endo apical debrider dental insert to be used in conjunction with Mectron Piezosurgery handpieces.
MECTRON SPA
EN1 -US
In Commercial Distribution

  • E322021700011010 ()
02170001-101

  • Dental ultrasonic surgical system handpiece tip

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

NuGrip® CMC Implant System - 10381780247692

Integra® NuGrip® The NuGripTemplate is used to assess coverage and establish sizing for a component.
Ascension Orthopedics, Inc.
TMP443S
In Commercial Distribution

  • M269TMP443S1 ()
  • 10381780247692 ()

  • Size Small; 4.52 in L
TMP-443-S

  • Surgical implant template, reusable

NuGrip® CMC Implant System - 10381780247685

Integra® NuGrip® The NuGripTemplate is used to assess coverage and establish sizing for a component.
Ascension Orthopedics, Inc.
TMP443M
In Commercial Distribution

  • M269TMP443M1 ()
  • 10381780247685 ()

  • Size Medium; 4.58 in L
TMP-443-M

  • Surgical implant template, reusable

NuGrip® CMC Implant System - 10381780247678

Integra® NuGrip® The NuGripTemplate is used to assess coverage and establish sizing for a component.
Ascension Orthopedics, Inc.
TMP443L
In Commercial Distribution

  • M269TMP443L1 ()
  • 10381780247678 ()

  • Size Large; 4.7 in L
TMP-443-L

  • Surgical implant template, reusable

TruArch® Subtalar Implant System - 10381780247548

Integra® TruArch® The TruArch Sterilization Tray is designed to contain, secure, and protect system devices.
Ascension Orthopedics, Inc.
TA-7000
Not in Commercial Distribution

  • M269TA70001 ()
  • 10381780247548 ()

  • 10 in L x 10 in W x 1.5 in H
TA-7000

  • Instrument tray, reusable

Integra® - 10381780247418

Integra®Total Foot System The snap-on drill guide is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
SDGTFS35
In Commercial Distribution

  • M269SDGTFS351 ()
  • 10381780247418 ()

  • 45.28 mm L x 3.78 mm inner dia
SDG-TFS-35

  • Surgical drill guide, reusable

Integra® - 10381780247401

Integra® Total Foot System The snap-on drill guide is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
SDGTFS27
In Commercial Distribution

  • M269SDGTFS271 ()
  • 10381780247401 ()

  • 30.57 mm L x 2.98 mm inner dia
SDG-TFS-27

  • Surgical drill guide, reusable

Integra® - 10381780247395

Integra® Total Foot System The snap-on drill guide is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
SDGTFS25
In Commercial Distribution

  • M269SDGTFS251 ()
  • 10381780247395 ()

  • 44.92 mm L x 2.8 mm inner dia
SDG-TFS-25

  • Surgical drill guide, reusable
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