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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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BISCO INC.
H-403A3P
Not in Commercial Distribution

  • D757H403A3P1 ()
H-403A3P

  • Preformed dental crown, temporary
ROM Plus®, Quality Control for Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-QC
In Commercial Distribution

  • 20814247020455 ()
  • 10814247020458 ()
  • 00814247020451 ()


  • Amniotic fluid leak detection device IVD
ROM Plus® Complete Kit Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-6000
In Commercial Distribution

  • 20814247020448 ()
  • 10814247020441 ()
  • 00814247020444 ()


  • Amniotic fluid leak detection device IVD
ROM Plus®, Easy Strip Quality Control for Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-QCS
In Commercial Distribution

  • 20814247020462 ()
  • 10814247020465 ()
  • 00814247020468 ()


  • Amniotic fluid leak detection device IVD
ROM Plus® Complete Kit Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-5025
In Commercial Distribution

  • 10814247020434 ()
  • 00814247020437 ()


  • Amniotic fluid leak detection device IVD
ROM Plus® Complete Test Kit
CLINICAL INNOVATIONS, LLC
ROM-5000
In Commercial Distribution

  • 20814247020424 ()
  • 10814247020427 ()
  • 00814247020420 ()


  • Amniotic fluid leak detection device IVD
ROM Plus® Easy Strip Complete Kit Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-1025
In Commercial Distribution

  • 00814247020406 ()
  • 10814247020403 ()
  • 20814247020400 ()


  • Amniotic fluid leak detection device IVD
Memory Staple 30 x 30-2 x 3mm / LRG
Wishbone Medical, Inc.
17624WB
Not in Commercial Distribution

  • B56217624WB0 ()


  • Orthopaedic bone staple, non-adjustable
Scott's Select Flowable Composite is a 41% filled (by volume) composite based on a resin system of BIS-GMA and triethylene glycol dimetacrylate. The filler has particle sizes ranging from sub-micron to 8 microns. Contains 2% Sodium Fluoride (by weight). There is about 1wt% catalysts, inhibitors and pigments. Shade/Color: D3. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5016
In Commercial Distribution

  • D77819950161 ()
  • D77819950160 ()

  • Weight: 2 Gram
199-5016

  • Dental composite resin
Scott's Select Flowable Composite is a 41% filled (by volume) composite based on a resin system of BIS-GMA and triethylene glycol dimetacrylate. The filler has particle sizes ranging from sub-micron to 8 microns. Contains 2% Sodium Fluoride (by weight). There is about 1wt% catalysts, inhibitors and pigments. Shade/Color: C4. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5014
In Commercial Distribution

  • D77819950141 ()
  • D77819950140 ()

  • Weight: 2 Gram
199-5014

  • Dental composite resin
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