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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SALVIN DENTAL SPECIALTIES, LLC
ISM-5
In Commercial Distribution

  • 00841336104303 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
HMO 70000 (BO coated) Quadrox i Adult, BO-VHK 71000 Venous Reservoir, BO-VHK 31000 Venous Res. Pediatric (MACE), BO-RF32 RotaFlow, Pall LG6 Arterial filter, Gas Filter
DATASCOPE CORP.
BO-TOP 23407
Not in Commercial Distribution

  • 00607567204805 ()
701056607

  • Cardiopulmonary bypass system blood tubing set
Gills Welsh I/A Cannula 23ga Irrigating 25ga Aspirating, Flat Olive Tip Straight, Angled 20 Degree shaft, 10mm from bend to tip, 23mm Overall Length
Crestpoint Management Limited
CA590
In Commercial Distribution

  • G412CA5900 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Gills Welsh I/A Cannula 23ga Irrigating 25ga Aspirating, Flat Olive Tip Right, Angled 20 Degree shaft, 10mm from bend to tip, 23mm Overall Length
Crestpoint Management Limited
CA585
In Commercial Distribution

  • G412CA5850 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Gills Welsh I/A Cannula 23ga Irrigating 25ga Aspirating, Flat Olive Tip Left, Angled 20 Degree shaft, 10mm from bend to tip, 23mm Overall Length
Crestpoint Management Limited
CA580
In Commercial Distribution

  • G412CA5800 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Interchangeable-Tip I/A system straight tip, 16 gauge outer sleeve, 21 gauge inner sleeve, 0.5mm aspiration port for rapid removal of visco material, stainless steel
AMBLER SURGICAL CORP.
Interchangeable-Tip I/A system straight tip
In Commercial Distribution

  • 00190660089320 ()
90-321E

  • Ophthalmic surgical irrigation/infusion/aspiration handle, reusable
Interchangeable-Tip I/A system curved tip, 16 gauge outer sleeve, 21 gauge inner sleeve, 0.5mm aspiration port for rapid removal of visco material, stainless steel
AMBLER SURGICAL CORP.
Interchangeable-Tip I/A system curved tip
In Commercial Distribution

  • 00190660089153 ()
90-322E

  • Ophthalmic surgical irrigation/infusion/aspiration handle, reusable
Diamond Dental Bur
ABRASIVE TECHNOLOGY, INC.
OSU DENT I - TWO STRIPER
In Commercial Distribution

  • B868CFKT001420 ()
  • B868CFKT001421 ()
CFKT00142

  • Diamond dental bur, reusable
HMO 71000 (BO coated) Quadrox i Adult with integral filter, BO-VHK 71000 Venous Reservoir, Prebypass filter w/o Vent Porous Media 3/8x1/2, Gas Filter
DATASCOPE CORP.
BO-TOP 38803
Not in Commercial Distribution

  • 00607567209466 ()
701067370R01

  • Cardiopulmonary bypass system blood tubing set
Steinert I Nucleus Claw Chopper, J-Shaped chopper with ambidextrous cutting edge, Angled/Vaulted 10mm from bend to tip, Round knurled Handle, 118mm total length, Stainless Steel
Diamatrix
H485-1-S
In Commercial Distribution

  • 00813059017994 ()
H485-1-S

  • Ocular hook/spatula/manipulator, reusable
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