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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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Pancreatic Flexi-Stent Kit includes Stent and Pusher Catheter.. This is a single-use device.
HOBBS MEDICAL, INC.
6504
In Commercial Distribution

  • M84965040 ()
6504

  • Polymeric pancreatic stent, non-bioabsorbable
Pancreatic Flexi-Stent Kit includes Stent and Pusher Catheter. This is a single-use device.
HOBBS MEDICAL, INC.
6503
In Commercial Distribution

  • M84965030 ()
6503

  • Polymeric pancreatic stent, non-bioabsorbable
MacDx Dark Adaptometer is a device to measure dark adaptation of the retina.
AMA Optics, Inc.
MACDX-01-PRO
In Commercial Distribution

  • G506MACDX010 ()
MACDX01

  • Adaptometer
The Vest Holder is intended to limit the movement of the patient's body.
Kenad SG Medical, Inc.
Protective Vest No Sleeve Xsmall
Not in Commercial Distribution

  • M1435040030 ()
50-4003

  • Limb/torso/head restraint, single-use
The Limb Holder is intended to limit the movement of the patient's limbs.
Kenad SG Medical, Inc.
Single Patient Protective Limb Holder
In Commercial Distribution

  • M143501500S0 ()
50-1500S

  • Limb/torso/head restraint, single-use
The Limb Holder is intended to limit the movement of the patient's limbs.
Kenad SG Medical, Inc.
Universal Blue Limb Holder 30in Tail
Not in Commercial Distribution

  • M143501500L1 ()
50-1500L

  • Limb/torso/head restraint, single-use
Suntan Unit. One Panel with ten 72" suntan lamps. Panel is wall mounted.
Medtek Lighting Corporation
1000HT
In Commercial Distribution

  • B343HT1000 ()

  • Area/Surface Area: 1311 Square inch
  • Weight: 180 Pound
1000HT

  • Ultraviolet tanning device
OsteoSurge300 Putty, 10cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. OsteoSurge300 is formulated into a putty form and is provided in a sterile, single use package.
ISOTIS ORTHOBIOLOGICS, INC.
56500100
In Commercial Distribution

  • M386565001001 ()
  • 10889981055851 ()

  • 10cc
56500100

  • Bone matrix implant, human-derived
OsteoSurge300 Putty, 2.5cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. OsteoSurge300 is formulated into a putty form and is provided in a sterile, single use package.
ISOTIS ORTHOBIOLOGICS, INC.
56500025
In Commercial Distribution

  • M386565000251 ()
  • 10889981055837 ()

  • 2.5cc
56500025

  • Bone matrix implant, human-derived
Accell Connexus, 10cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
02-3000-100
In Commercial Distribution

  • M3860230001001 ()
  • 10889981055493 ()

  • 10cc
02-3000-100

  • Bone matrix implant, human-derived
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