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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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CARBIDE BURS FG 5 DARBY
DARBY DENTAL SUPPLY, LLC
FG 5
In Commercial Distribution

  • 00889813004944 ()
  • 00889813004937 ()
9525120

  • Carbide dental bur, reusable
CARBIDE BURS RA 5 DARBY
DARBY DENTAL SUPPLY, LLC
RA 5
In Commercial Distribution

  • 00889813007006 ()
  • 00889813006993 ()
9525580

  • Carbide dental bur, reusable
Calcium compound bone void filler with DBM (5cc), Previously sold under Trabexus® EB brand name.
Vivorte, Inc
5 cc
In Commercial Distribution

  • W4146EB0005T0475 ()
130703-05

  • Cadaveric-donor/synthetic mineral bone graft
AMPLIM Ovulation Test Kit (20 Ovulation Test+ 5 Early Pregnancy Tests)
AMPLIM, LLC
A8177W-20+5
In Commercial Distribution

  • 00810477026416 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
AMPLIM Ovulation Test Kit (20 Ovulation Test+ 5 Early Pregnancy Tests)
AMPLIM, LLC
A8177-20+5
In Commercial Distribution

  • 00810477026287 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Symmetric Total Knee Tibial Tray Size 5
SIGNAL MEDICAL CORPORATION
Size: 5
In Commercial Distribution

  • B04622021250 ()
22-02-125

  • Coated unicondylar knee tibia prosthesis
Self-contained biological indicator for use in steam sterilization. Log 5. 50 count package.
MESA LABORATORIES, INC.
Log 5
Not in Commercial Distribution

  • M985PS235501 ()
  • M985PS235500 ()
PS2-3-5-50

  • Biological sterilization indicator
Self-contained biological indicator for use in steam sterilization processes. Log 5 population. 25 count box.
MESA LABORATORIES, INC.
Log 5
In Commercial Distribution

  • M985SEZS5251 ()
  • M985SEZS5250 ()
SEZS/525

  • Biological sterilization indicator
Biological Indicator intended for steam sterilization (121C). Contains spores of Geobacillus stearothermophilus. 50 units / box
MESA LABORATORIES, INC.
Log 5
Not in Commercial Distribution

  • M985PS2351 ()
  • M985PS23550 ()
PS2-3-5-50

  • Biological sterilization indicator
No Description
ZIMMER DENTAL INC.
OPT/5
In Commercial Distribution

  • 00889024016019 ()

  • Ø4.8mm, Ø5.2mm


  • Dental implant suprastructure, temporary, preformed, single-use
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