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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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Resection Stylus (2-10mm)
Orthalign, Inc.
401575
In Commercial Distribution

  • 00858704006077 ()
401575

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Resection Stylus (2-10mm)
Orthalign, Inc.
401285
In Commercial Distribution

  • 00858704006060 ()
401825

  • Orthopaedic surgical procedure kit, non-medicated, reusable
KneeAlign 2 Instrument Kit
Orthalign, Inc.
402064-07
In Commercial Distribution

  • 00858704006053 ()
402064-07

  • Orthopaedic surgical procedure kit, non-medicated, reusable
KneeAlign 2 Instrument Kit
Orthalign, Inc.
402064-06
In Commercial Distribution

  • 00858704006046 ()
402064-06

  • Orthopaedic surgical procedure kit, non-medicated, reusable
KneeAlign 2 Instrument Kit
Orthalign, Inc.
402064-05
In Commercial Distribution

  • 00858704006039 ()
402064-05

  • Orthopaedic surgical procedure kit, non-medicated, reusable
KneeAlign 2 Instrument Kit
Orthalign, Inc.
402064-04
In Commercial Distribution

  • 00858704006022 ()
402064-04

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Reference Sensor 2
Orthalign, Inc.
133632
In Commercial Distribution

  • 00858704006015 ()
133632

  • Orthopaedic stereotactic surgery system
KneeAlign 2 Unit
Orthalign, Inc.
133631
In Commercial Distribution

  • 10858704006005 ()
  • 00858704006008 ()
133631

  • Orthopaedic stereotactic surgery system
Intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure.
DENTERPRISE INTERNATIONAL, INC.
e2V Size #2
In Commercial Distribution

  • 00858475006085 ()


  • Dental digital imaging sensor, intraoral
To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas Chemistry Systems.
STANBIO LABORATORY, L.P.
A469-98
Not in Commercial Distribution

  • 00657498001790 ()
A469-98

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
No Description
DIGIRAD CORPORATION
Mobile XPOL
In Commercial Distribution

  • 00850816007065 ()


  • SPECT system, annular detector array
No Description
DIGIRAD CORPORATION
XPOD International
In Commercial Distribution

  • 00850816007058 ()


  • SPECT system, annular detector array
No Description
DIGIRAD CORPORATION
Mobile XPOD
In Commercial Distribution

  • 00850816007041 ()


  • SPECT system, annular detector array
No Description
DIGIRAD CORPORATION
XPOD
In Commercial Distribution

  • 00850816007034 ()


  • SPECT system, annular detector array
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
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