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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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UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.
Alcon Laboratories, Inc.
8065753066
In Commercial Distribution

  • 10380657530660 ()
  • 00380657530663 ()
8065753066

  • Perfluoropropane refillable cylinder
Uterine Balloon Therapy System with Fluid Circulation
Ethicon Inc.
TC013
Not in Commercial Distribution

  • H206TC0131 ()
  • 20705031050744 ()
TC013

  • Circulating-fluid endometrial-ablation catheter
Occluder, Internal Vessel, Temporary
GENZYME CORPORATION
LG250
Not in Commercial Distribution

  • 20358468019046 ()

  • one 2.5 mL syringe with 1 cannula (3.0 x 80 mm)
  • Total Volume: 2.5 Milliliter


  • Intravascular occluding solution kit
Occluder, Internal Vessel, Temporary
GENZYME CORPORATION
LG100
Not in Commercial Distribution

  • 20358468019039 ()

  • Total Volume: 1 Milliliter
  • one 1.0 mL syringe with three cannulae (1.0 x 40 mm, 1.5 x 40 mm and 3.0 x 80 mm)


  • Intravascular occluding solution kit
PCM Inserter
Nuvasive, Inc.
7690901
In Commercial Distribution

  • 00887517083562 ()


  • Surgical implant/trial-implant/sizer holder, reusable
PCM Loading Block
Nuvasive, Inc.
7690900
In Commercial Distribution

  • 00887517083555 ()


  • Surgical implant/trial-implant/sizer holder, reusable
ANTERTIOR CHAMFER REAMER, 7.5mm
Stryker GmbH
925-0016
Not in Commercial Distribution

  • 00886385018102 ()

  • Outer Diameter: 7.5 Millimeter


  • Bone-resection orthopaedic reamer, reusable
PUNCH 6972425 RAIL
MEDTRONIC SOFAMOR DANEK, INC.
6972425
In Commercial Distribution

  • 00613994490735 ()

  • Depth: 12.0 Millimeter
  • Height: 5.0 Millimeter


  • Bone-resection orthopaedic reamer, reusable
Tunneling Lance and Handle
Thoratec Corporation
10010372GBL
In Commercial Distribution

10010372GBL

  • Vascular graft tunneller
ACCESSORY 6996T TOOL TUNNELING FINAL PK
MEDTRONIC, INC.
6996T
In Commercial Distribution

  • 00681490743761 ()


  • Vascular graft tunneller
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