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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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ORLocate RFID Gauze Lap Sponge is used with the ORLocate Sponge Solution System.
Steris Corporation
ORLocate Lap Sponge
Not in Commercial Distribution

  • 55060356150071 ()
  • 15060356150073 ()
  • 05060356150076 ()
LTS1818X45

  • Radiopaque woven surgical sponge
Chang Style Areola Marker, Double Ended, Quadrants, One Size 34mm, Other Is 36mm
Med Saver, Inc.
187570-3436
In Commercial Distribution

  • 00194613094072 ()


  • Skin marking guide, reusable
Pink 50 sheets. SternTek base plate material is a light-cure material for the preparation of base plates. Polymeization is achieved by the usual UV-light and/or Halogen light units.
STERNGOLD DENTAL LLC
222004
In Commercial Distribution

  • 00841549118500 ()


  • Dental appliance fabrication material, resin
This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Liquid Assayed Chemistry Control Premium Plus is for the control of accuracy.
RANDOX LABORATORIES LIMITED
LAN4214
In Commercial Distribution

  • 05055273214536 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Liquid Assayed Chemistry Control Premium Plus is for the control of accuracy.
RANDOX LABORATORIES LIMITED
LAL4213
In Commercial Distribution

  • 05055273209006 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Liquid Assayed Chemistry Control Premium Plus is for the control of accuracy.
RANDOX LABORATORIES LIMITED
LAE4215
In Commercial Distribution

  • 05055273208986 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
Klenzyme Enzymatic Presoak and Cleaner 1-Gallon Bag, is a highly effective protease-based enzyme that is especially effective in the removal of protein from a wide variety of medical devices.
STERIS CORPORATION
1673BXEC
In Commercial Distribution

  • 50724995045284 ()
  • 00724995045289 ()
1673BXEC

  • Medical device cleaning agent
The VS50 is a wall-mounted long-length imaging radiographic cassette holder. This device is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use.
Del Medical, Inc.
VS50
In Commercial Distribution

  • 00858340006387 ()


  • X-ray film cassette holder
TDNexLabs is a Laboratory Information System (LIS) (software product) intended to be used for the management of clinical information. TDNexLabs is intended to be used only by health professionals.
TECHNIDATA
TDNexLabs
In Commercial Distribution

  • 03770027519003 ()


  • Clinical laboratory information system application software
The FSH ELISA is intended for the quantitative determination of FSH concentration in human serum. The assay is useful in the diagnosis and treatment of pituitary and gonadal disorders.
DRG International Inc
EIA-1785
Not in Commercial Distribution

  • 00840239017857 ()
EIA-1785

  • Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA)
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