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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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Vital Signs Patient Simulator
FLUKE ELECTRONICS CORPORATION
PROSIM 2
In Commercial Distribution

  • 00850540007089 ()
4318341

  • Multi-parameter device tester
Intended to be used to fabricate teeth models, which can be used for fabricating Try-In Dentures for cosmetic and not masticatory purposes.
Sprintray, Inc.
SRI-0202031
In Commercial Distribution

  • 10850039704151 ()
  • 00850039704154 ()

  • Total Volume: 1 Liter
SRI-0202031

  • Dental appliance fabrication material, resin
Indicated for the fabrication, by additive manufacturing, of Indirect Bonding Tray
Sprintray, Inc.
SRI-0202012
In Commercial Distribution

  • 10850039704052 ()
  • 00850039704055 ()

  • Total Volume: 1 Liter
SRI-0202012

  • Dental appliance fabrication material, resin
ANTI-CCP/2 ANTIBODY ELISA TEST KIT, 192 TESTS
THERA-TEST LABORATORIES, INC
104-122
In Commercial Distribution

  • 00854473003019 ()
104-122

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA)
TRICE MI-EYE ANGLED NEEDLESCOPE, 120MM
TRICE MEDICAL, INC.
T215-120
Not in Commercial Distribution

  • 00857356008118 ()


  • Rigid optical arthroscope, single-use
Tablet for use as part of the mi-eye 2 System.
TRICE MEDICAL, INC.
T200-020
Not in Commercial Distribution

  • 00857356008064 ()


  • Rigid optical arthroscope, single-use
MI-EYE 2 SYSTEM, MI-ULTRA, EN
TRICE MEDICAL, INC.
T200-010
Not in Commercial Distribution

  • 00857356008026 ()


  • Rigid optical arthroscope, single-use
Dilator 2
Si-Bone Inc.
501161
In Commercial Distribution

  • 00855369008491 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Decorticator 2
Si-Bone Inc.
400222
In Commercial Distribution

  • 00855369008217 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
No Description
QARDIO, INC.
B200
In Commercial Distribution

  • 10854894005248 ()
  • 00854894005241 ()
B200-IAW

  • Bioelectrical body composition analyser
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