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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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The Integra Ti6 Internal Fixation System is comprised of Digital screws used for bone fixation of the hand and foot following trauma or osteotomy. The Digital Screw is a cannulated, threaded bone screw which is offered in a 2.0mm diameter with lengths of 24 to 50mm. The system includes titanium and stainless steel instruments to facilitate the placement of the screws.
Ascension Orthopedics, Inc.
TI6DIGITIMP
Not in Commercial Distribution

  • M268TI6DIGITIMP1 ()
  • 10381780074304 ()
TI6DIGITIMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
PASCAL Synthesis, ASSY, SLC AND ESF, 577nm, SYNTHESIS III, TOPCON D7 aka SA-06175
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 577
In Commercial Distribution

  • 00855005006201 ()
SA-06415

  • Ophthalmic solid-state laser system, photodisruption
PASCAL Synthesis TwinStar (577/638) CONSOLE, PA-03, SYNTHESIS III (PACKED)
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 577 /638
In Commercial Distribution

  • 00855005006188 ()
SA-06288

  • Ophthalmic solid-state laser system, photodisruption
(577) CONSOLE PA-03, PB-2, SYNTHESIS III, JAPAN (PACKED) RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 577
In Commercial Distribution

  • 00855005006164 ()
SA-06410

  • Ophthalmic solid-state laser system, photodisruption
(532) CONSOLE PA-03, PB-2, SYNTHESIS III, JAPAN (PACKED) RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 532
In Commercial Distribution

  • 00855005006157 ()
SA-06409

  • Ophthalmic solid-state laser system, photodisruption
(532) CONSOLE PA-03, SYNTHESIS III PACKED B RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 532
In Commercial Distribution

  • 00855005006027 ()
SA-06284

  • Ophthalmic solid-state laser system, photodisruption
(532) PASCAL, SYNTHESIS III CONSOLE (PACKED) A1 RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 532
In Commercial Distribution

  • 00855005006003 ()
SA-06280

  • Ophthalmic solid-state laser system, photodisruption
PASCAL Synthesis, ASSY, SLC AND ESF, 532nm, SYNTHESIS III, TOPCON D7 aka SA-06174
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 532
In Commercial Distribution

  • 00855005006195 ()
SA-06414

  • Ophthalmic solid-state laser system, photodisruption
PASCAL Synthesis TwinStar (577/638) CONSOLE, PA-03, SYNTHESIS III JAPAN (PACKED)
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 577 /638
In Commercial Distribution

  • 00855005006171 ()
SA-06325

  • Ophthalmic solid-state laser system, photodisruption
PASCAL Synthesis SLC & ESF (577 nm) for BQ B1 RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
Synthesis SLC & ESF 577
In Commercial Distribution

  • 00855005006096 ()
SA-06196

  • Ophthalmic solid-state laser system, photodisruption
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