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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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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®, 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® 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
No Description
BISCO INC.
H-403A3P
Not in Commercial Distribution

  • D757H403A3P1 ()
H-403A3P

  • Preformed dental crown, temporary
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 Microhybrid Composite is indicated for direct aesthetic restoration of anterior and posterior teeth and can be used in limited occlusal function. Microhybrid Composite is a light activated, resin based dental restorative material. Microhybrid Composite consists of approximately 75wt% (54vol%) silanated 0.7 micron Barium glass and 0.01 micron silica, approximately 25wt$ Bis-GMA based dimethacrylate system, and approximately 1wt% catalysts, inhibitors and pigments. Shade/color: C1. Instructions for use and SDS available at https://www.scottsdental.com/microhybrid-composite-syringe-scott-s-select.html.
SCOTT'S DENTAL SUPPLY L.L.C.
199-2007
In Commercial Distribution

  • D77819920070 ()

  • Weight: 4.5 Gram
199-2007

  • Dental composite resin
Scott’s Select Microhybrid Composite is indicated for direct aesthetic restoration of anterior and posterior teeth and can be used in limited occlusal function. Microhybrid Composite is a light activated, resin based dental restorative material. Microhybrid Composite consists of approximately 75wt% (54vol%) silanated 0.7 micron Barium glass and 0.01 micron silica, approximately 25wt$ Bis-GMA based dimethacrylate system, and approximately 1wt% catalysts, inhibitors and pigments. Shade/color: B3. Instructions for use and SDS available at https://www.scottsdental.com/microhybrid-composite-syringe-scott-s-select.html.
SCOTT'S DENTAL SUPPLY L.L.C.
199-2006
In Commercial Distribution

  • D77819920060 ()

  • Weight: 4.5 Gram
199-2006

  • Dental composite resin
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