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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Liquichek ToRCH Plus Control, Positive (An unassayed (human) Serology control.)
BIO-RAD LABORATORIES, INC.
239
In Commercial Distribution

  • 00847661000235 ()
239

  • Treponema pallidum reagin antibody IVD, control
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control
  • Multiple infectious organism/newborn TORCH screen IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
M/L Uni-Planar Screw, Extended Tab, 6.5mm X 30mm
Seaspine Orthopedics Corporation
MD1-136530
In Commercial Distribution

  • 10889981292805 ()
MD1-136530

  • Bone-screw internal spinal fixation system, non-sterile
M/L Uni-Planar Screw, Extended Tab, 5.5mm X 30mm
Seaspine Orthopedics Corporation
MD1-135530
In Commercial Distribution

  • 10889981292614 ()
MD1-135530

  • Bone-screw internal spinal fixation system, non-sterile
M/L Uni-Planar Screw, Extended Tab, 5.5mm X 25mm
Seaspine Orthopedics Corporation
MD1-135525
In Commercial Distribution

  • 10889981292607 ()
MD1-135525

  • Bone-screw internal spinal fixation system, non-sterile
M/L Uni-Planar Screw, Extended Tab, 4.5mm X 45mm
Seaspine Orthopedics Corporation
MD1-134545
In Commercial Distribution

  • 10889981292454 ()
MD1-134545

  • Bone-screw internal spinal fixation system, non-sterile
M/L Uni-Planar Screw, Extended Tab, 4.5mm X 40mm
Seaspine Orthopedics Corporation
MD1-134540
In Commercial Distribution

  • 10889981292447 ()
MD1-134540

  • Bone-screw internal spinal fixation system, non-sterile
TRANSFER ECHO FOR PRE-KOH TG M PLATFORM, INTRAORAL SCANBODY
SWEDEN & MARTINA SPA
A-TG-INT-CAMTRA-M
In Commercial Distribution

  • D7701214033 ()
A-TG-INT-CAMTRA-M

  • Dental implant/prosthesis surgical procedure kit
InspiredBath Transfer Product Description: Ultima Assembly Kit, S/M
Drive Devilbiss Healthcare
CH-8130
Not in Commercial Distribution

  • 00822383975030 ()


  • Patient lifting system bath chair
STAT PROFILE pHOx PLUS/L/C/M SODIUM SENSOR
NOVA BIOMEDICAL CORPORATION
PLUS/L/C
In Commercial Distribution

  • 00385480278102 ()
27810

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to accept only STAT-Site® Mß-HB CODE Keys and STAT-Site® Mß-HB Test Strips. This test system is intended or the quantitative determination of ß-hydroxybutyrate in serum or plasma.
STANBIO LABORATORY, L.P.
401020
In Commercial Distribution

  • 00657498000731 ()
401020

  • Single-channel clinical chemistry analyser IVD, point-of-care
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