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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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Ti6® Internal Fixation System - 10381780244998

Integra® Ti6® The drill bit is a cutting tool used to create 4.0 mm cylindrical holes.
Ascension Orthopedics, Inc.
FS2004
In Commercial Distribution

  • M269FS20041 ()
  • 10381780244998 ()

  • 100 mm L x 2.7 mm dia tip
FS2004

  • Cannulated surgical drill bit, single-use

Ti6® Internal Fixation System - 10381780244981

Integra® Ti6® The drill bit is a cutting tool used to create 3.0 mm cylindrical holes.
Ascension Orthopedics, Inc.
FS2003
In Commercial Distribution

  • M269FS20031 ()
  • 10381780244981 ()

  • 90 mm L x 2.0 mm dia tip
FS2003

  • Cannulated surgical drill bit, single-use

Ti6® Internal Fixation System - 10381780244974

Integra® Ti6® The drill bit is a cutting tool used to create 2.5 mm cylindrical holes.
Ascension Orthopedics, Inc.
FS2002
In Commercial Distribution

  • M269FS20021 ()
  • 10381780244974 ()

  • 75.65 mm L x 1.7 mm dia tip
FS2002

  • Cannulated surgical drill bit, single-use

Ti6® Internal Fixation System - 10381780244967

Integra® Ti6® The drill bit is a cutting tool used to create 2.0 mm cylindrical holes.
Ascension Orthopedics, Inc.
FS2001
In Commercial Distribution

  • M269FS20011 ()
  • 10381780244967 ()

  • 65.4 mm L x 1.4 mm dia tip
FS2001

  • Cannulated surgical drill bit, single-use

Ti6® Internal Fixation System - 10381780244783

Integra® Ti6® The driver shaft is used to create holes in conjunction with the Ti6 digital fusion screws.
Ascension Orthopedics, Inc.
DS3010
In Commercial Distribution

  • M269DS30101 ()
  • 10381780244783 ()

  • 88 mm L x 2.67 mm dia
DS3010

  • Surgical screwdriver, reusable

Ti6® Internal Fixation System - 10381780247562

Integra® Ti6® The Ti6 Base Instrument Set contains instruments used to aid in the implantation of the Ti6 Screws.
Ascension Orthopedics, Inc.
TI6INSTP
Not in Commercial Distribution

  • M269TI6INSTP1 ()
  • 10381780247562 ()

  • 6.97in L x 5.80in W x 1.50in H
TI6INSTP

  • Instrument tray, reusable

Ti6® Internal Fixation System - 10381780245117

Integra® Ti6® The Ti6 cannulated CounterSink is used to add space or clearance for the head of a TC-Series 3.0 or 4.0mm screw.
Ascension Orthopedics, Inc.
FS2185
Not in Commercial Distribution

  • M269FS21851 ()
  • 10381780245117 ()

  • 4.724 mm L x .160 mm tip dia
FS2185

  • Surgical screwdriver, reusable

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161012432

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full with Qid 625 cc
Establishment Labs S.A.
ERSF-625Q
In Commercial Distribution

  • 07445161012432 ()
ERSF-625Q

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161012425

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full with Qid 550 cc
Establishment Labs S.A.
ERSF-550Q
In Commercial Distribution

  • 07445161012425 ()
ERSF-550Q

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161012418

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full with Qid 500 cc
Establishment Labs S.A.
ERSF-500Q
In Commercial Distribution

  • 07445161012418 ()
ERSF-500Q

  • Silicone gel-filled breast implant, smooth-surface
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