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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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PRO OSTEON 200 - 00888480584162

Porous Hydroxyapatite Bone Graft Substitute
Biomet Orthopedics, LLC
2B040
In Commercial Distribution

  • 00888480584162 ()

  • 10 mm x 10 mm x 40 mm Block (4.0 cc)
2B040

  • Bone matrix implant, synthetic, non-antimicrobial

SteinerBio - 00860010170250

No Description
STEINER BIOTECHNOLOGY LLC.
SteinerBio OsseoConduct Macro Granules 1000-2000 microns 1.0 cc
In Commercial Distribution

  • 00860010170250 ()


  • Synthetic bone graft

SteinerBio - 00860010170243

No Description
STEINER BIOTECHNOLOGY LLC.
SteinerBio OsseoConduct Macro Granules 1000-2000 microns 0.5 cc
In Commercial Distribution

  • 00860010170243 ()


  • Synthetic bone graft

steinerBio - 00860010170236

No Description
STEINER BIOTECHNOLOGY LLC.
SteinerBio OsseoConduct Standard Granules 500-1000 microns 1.0 cc
In Commercial Distribution

  • 00860010170236 ()


  • Synthetic bone graft

SteinerBio - 00860010170229

No Description
STEINER BIOTECHNOLOGY LLC.
SteinerBio OsseoConduct Standard Granules 500-1000 microns 0.5 cc
In Commercial Distribution

  • 00860010170229 ()


  • Synthetic bone graft

SteinerBio - 00860010170212

No Description
STEINER BIOTECHNOLOGY LLC.
SteinerBio OsseoConduct Perio Granules 250-500 microns 1.0 cc
In Commercial Distribution

  • 00860010170212 ()


  • Synthetic bone graft

SteinerBio - 00860010170205

No Description
STEINER BIOTECHNOLOGY LLC.
SteinerBio OsseoConduct Perio Granules 250-500 microns 0.5 cc
In Commercial Distribution

  • 00860010170205 ()


  • Synthetic bone graft

OsteoSurge 300 Putty - 10889981055844

OsteoSurge300 Putty,5 cc - 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.
56500050
In Commercial Distribution

  • M386565000501 ()
  • 10889981055844 ()

  • 5cc
56500050

  • Bone matrix implant, human-derived

inFlow Intraurethral Valve-Pump - 08625630003027

Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003027 ()

  • Length: 30 Millimeter
  • Length: 35 Millimeter
  • Length: 40 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511

  • Intraurethral valve/pump

ReadyCric Kit - 00857048006477

One time use sterile emergency airway kit that contains (1) Disposable Scalpel #10 blade, (1) Endotracheal Tube, 6.0 mm cuffed, (1) 10 cc syringe, (1) 35 cm Bougie and Twill Tape.
H&H MEDICAL CORPORATION
Version 5
In Commercial Distribution

  • 00857048006477 ()

  • Length: 9.25 Inch
  • Width: 4.0 Inch
  • Height: 1.75 Inch
HHRCK01

  • Cricothyrotomy kit, single-use
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