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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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Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14150
In Commercial Distribution

  • B091141500 ()

  • Outer Diameter: 10 Millimeter
14150

  • Orbital sphere implant
Malar Implant Teardrop Standard
Stryker Leibinger GmbH & Co. KG
6323
In Commercial Distribution

  • 07613252170297 ()

  • Length: 30.0 Millimeter
  • Diameter: 5.6 Millimeter
6323

  • Orbital sphere implant
8x10.5 16 INST Q CASSETTE, OCEAN BLUE
HU-FRIEDY MFG. CO., LLC
IMN41611Q
Not in Commercial Distribution

  • 10889950067175 ()
IMN41611Q

  • Device sterilization/disinfection container, reusable
8X10.5 12 INST Q CASSETTE, OCEAN BLUE
HU-FRIEDY MFG. CO., LLC
IMN41211Q
Not in Commercial Distribution

  • 10889950066840 ()
IMN41211Q

  • Device sterilization/disinfection container, reusable
INSTRUMENT 922502S Q C STRT PED SPATULA
MEDTRONIC SOFAMOR DANEK, INC.
922502S
In Commercial Distribution

  • 00681490912235 ()


  • General-purpose surgical spatula
INSTRUMENT 922501L Q C LONG SQUARE AWL
MEDTRONIC SOFAMOR DANEK, INC.
922501L
In Commercial Distribution

  • 00681490912211 ()


  • Bone awl, reusable
INSTRUMENT 922501S Q C SHORT SQUARE AWL
MEDTRONIC SOFAMOR DANEK, INC.
922501S
In Commercial Distribution

  • 00681490912204 ()


  • Bone awl, reusable
F&P Pilairo Q Nasal Pillows Mask
FISHER & PAYKEL HEALTHCARE LIMITED
400421
In Commercial Distribution

  • 09420012427076 ()
  • 09420012427069 ()
400421

  • CPAP/BPAP nasal mask, reusable
Zest Q Plus Nasal Mask (Sleep Lab)
FISHER & PAYKEL HEALTHCARE LIMITED
400446SL
In Commercial Distribution

  • 09420012425546 ()
  • 09420012427335 ()
400446SL

  • CPAP/BPAP nasal mask, reusable
Zest Q Standard Nasal Mask (Sleep Lab)
FISHER & PAYKEL HEALTHCARE LIMITED
400445SL
In Commercial Distribution

  • 09420012427328 ()
  • 09420012425539 ()
400445SL

  • CPAP/BPAP nasal mask, reusable
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