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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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Seamless Viral Barrier End, Polyurethane, 1.18"D Tapered to 4"W x 24"L, Non-sterile, Pre-Gelled Extended Field Ultrasound Probe & Cord Cover, Vaginal/Rectal, Rolled, Individually Wrapped
SHEATHING TECHNOLOGIES, INC.
50001-77244
In Commercial Distribution

  • 20842418102662 ()
  • 10842418102665 ()
  • 00842418102668 ()


  • Body-orifice ultrasound imaging transducer cover, basic, non-sterile
  • Body-surface ultrasound imaging transducer cover
  • Skin topical coupling gel
50001-27964, Case, Polyurethane, 7/8"D Tapered to 4"W x 96"L, Non-Sterile, Pre-Gelled Extended Field Ultrasound Probe & Cord Cover, Vaginal/Rectal, Rolled
SHEATHING TECHNOLOGIES, INC.
50001-27964
In Commercial Distribution

  • 20842418102624 ()
  • 10842418102627 ()
  • 00842418102620 ()


  • Body-orifice ultrasound imaging transducer cover, basic, non-sterile
  • Body-surface ultrasound imaging transducer cover
  • Skin topical coupling gel
Polyurethane, 7/8"D Tapered to 4"W x 36"L, Non-Sterile, Pre-Gelled Extended Field Ultrasound Probe & Cord Cover, Vaginal/Rectal, Rolled
SHEATHING TECHNOLOGIES, INC.
50001-27364
In Commercial Distribution

  • 20842418102617 ()
  • 10842418102610 ()
  • 00842418102613 ()


  • Body-orifice ultrasound imaging transducer cover, basic, non-sterile
  • Body-surface ultrasound imaging transducer cover
  • Skin topical coupling gel
No Description
Orasure Technologies, Inc.
1001-0323
In Commercial Distribution

  • 00608337000054 ()


  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control
EBV IgG Control Lot Data
BIO-RAD LABORATORIES, INC.
6631240
In Commercial Distribution

  • 00847865000154 ()

  • 1 Each
6631240

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control
  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
EBV IgG Control Set
BIO-RAD LABORATORIES, INC.
6631230
In Commercial Distribution

  • 00847865000147 ()

  • 4 Vials
  • Total Volume: 1.5 Milliliter
6631230

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control
  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
EBV IgG Calibrator Lot Data
BIO-RAD LABORATORIES, INC.
6631220
In Commercial Distribution

  • 00847865000130 ()

  • 1 Each
6631220

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, calibrator
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, calibrator
  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, calibrator
EBV IgG Calibrator Set
BIO-RAD LABORATORIES, INC.
6631200
In Commercial Distribution

  • 00847865000123 ()

  • 7 Vials
  • Total Volume: 0.5 Milliliter
6631200

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, calibrator
  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, calibrator
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, calibrator
BioSign Flu Control Kit (5 Postive/ 5 Negative)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-03
In Commercial Distribution

  • 10743816001492 ()
BSP-510C-03

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control
Status Flu Control Kit (5 Flu A/5 Flu B)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-02
In Commercial Distribution

  • 10743816001423 ()
BSP-510C-02

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control
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