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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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FlexiDisc 5/8 Superfine - D7794014581

No Description
COSMEDENT, INC.
401458
In Commercial Distribution

  • D7794014581 ()


  • Dental abrasive disk, single-use

FlexiDisc 5/8 Fine - D7794013581

No Description
COSMEDENT, INC.
401358
In Commercial Distribution

  • D7794013581 ()


  • Dental abrasive disk, single-use

FlexiDisc 5/8 Medium - D7794012581

No Description
COSMEDENT, INC.
401258
In Commercial Distribution

  • D7794012581 ()


  • Dental abrasive disk, single-use

CYSTATHIONINE PLUS LEVEL 5 - B800CYST5LC0

CYSTATHIONINE PLUS LEVEL 5
UTAK LABORATORIES, INC.
CYST+ 5 LC
In Commercial Distribution

  • B800CYST5LC5 ()
  • B800CYST5LC0 ()

  • Total Volume: 5 Milliliter
CYST+ 5 LC

  • Multiple-type clinical chemistry analyte profile IVD, control

BUSULFAN CALIBRATOR LEVEL 5 - B800BUSCAL5SJCR0

BUSULFAN CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
BUS CAL 5 SJCR
In Commercial Distribution

  • B800BUSCAL5SJCR5 ()
  • B800BUSCAL5SJCR0 ()

  • Total Volume: 5 Milliliter
BUS CAL 5 SJCR

  • Multiple drugs of abuse IVD, control

Validity Control Level 5 - B800170140

Validity Control Level 5
UTAK LABORATORIES, INC.
17014
In Commercial Distribution

  • B800170140 ()
  • B800170145 ()

  • Total Volume: 25 Milliliter
17014

  • Multiple urine analyte IVD, control

DAU CALIBRATOR LEVEL 5 - B80004240000050

No Description
UTAK LABORATORIES, INC.
DAU CAL 5 V4 F SEMCE
In Commercial Distribution

  • B80004240000050 ()
  • B80004240000051 ()
  • B80004240000052 ()
  • B80004240000053 ()
  • B80004240000056 ()
  • B80004240000057 ()
  • B80004240000058 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

Zirconia Clear 5 95H14 - D800ZRSF8021

Content: 1 piece Height: 14 mm
ZIRKONZAHN SRL
ZRSF8021
In Commercial Distribution

  • D800ZRSF8021 ()


  • Dental appliance fabrication material, ceramic

Prettau® Zirconia 5 - D800ZRAD0301

Content: 1 piece Height: 16 mm Highly translucent zirconia for single crowns and small bridges (fully anatomic structures or reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAD0301
In Commercial Distribution

  • D800ZRAD0301 ()


  • Dental bridge, ceramic

ARGENCO 60S (5 dwt) - D818120318

Gold based noble metal
ARGEN CORPORATION, THE
120318
In Commercial Distribution

  • D818120318 ()
120318

  • Dental casting noble alloy
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