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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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20PR 15X30CM XMT R HG CP F/PANRMC
CARESTREAM HEALTH, INC.
X-OMATIC Regular Screens
Not in Commercial Distribution

  • 60889971584465 ()
1584465

  • X-ray intensifying screen
The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON200) for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-101V
In Commercial Distribution

  • ACCCARTV101 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set
The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON200) for draining and monitoring of CSF flow from the lumbar region.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-200L
In Commercial Distribution

  • ACCCARTL200 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set
The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-101
In Commercial Distribution

  • ACCCART101 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set
The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON100) for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-100
Not in Commercial Distribution

  • ACCCART100 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set
Precision System Kit with Short Extension Tube and HV Bone Cement
STRYKER CORPORATION
0507589000
In Commercial Distribution

  • 37613252018316 ()
  • 07613252018315 ()
0507-589-000

  • Orthopaedic cement, non-antimicrobial
No Description
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
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: C2. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5013
In Commercial Distribution

  • D77819950131 ()
  • D77819950130 ()

  • Weight: 2 Gram
199-5013

  • 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: B1. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5011
In Commercial Distribution

  • D77819950111 ()
  • D77819950110 ()

  • Weight: 2 Gram
199-5011

  • 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: OPAQUE Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5010
In Commercial Distribution

  • D77819950101 ()
  • D77819950100 ()

  • Weight: 2 Gram
199-5010

  • 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: C3. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5009
In Commercial Distribution

  • D77819950091 ()
  • D77819950090 ()

  • Weight: 2 Gram
199-5009

  • 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: C1. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5008
In Commercial Distribution

  • D77819950081 ()
  • D77819950080 ()

  • Weight: 2 Gram
199-5008

  • 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: B3. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5007
In Commercial Distribution

  • D77819950071 ()
  • D77819950070 ()

  • Weight: 2 Gram
199-5007

  • 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: B2. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5006
In Commercial Distribution

  • D77819950061 ()
  • D77819950060 ()

  • Weight: 2 Gram
199-5006

  • 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: A4. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5005
In Commercial Distribution

  • D77819950051 ()
  • D77819950050 ()

  • Weight: 2 Gram
199-5005

  • 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: A3.5. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5004
In Commercial Distribution

  • D77819950041 ()
  • D77819950040 ()

  • Weight: 2 Gram
199-5004

  • 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: A3. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5003
In Commercial Distribution

  • D77819950031 ()
  • D77819950030 ()

  • Weight: 2 Gram
199-5003

  • 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: A2. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5002
In Commercial Distribution

  • D77819950021 ()
  • D77819950020 ()

  • Weight: 2 Gram
199-5002

  • 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: A1. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5001
In Commercial Distribution

  • D77819950011 ()
  • D77819950010 ()

  • Weight: 2 Gram
199-5001

  • Dental composite resin
Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: C1. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3007
In Commercial Distribution

  • D77819930070 ()

  • Weight: 4.5 Gram
199-3007

  • Dental composite resin
Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: B3 SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3006
In Commercial Distribution

  • D77819930060 ()

  • Weight: 4.5 Gram
199-3006

  • Dental composite resin
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