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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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Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 182 days at 5°C.
Temptime Corporation
F6
In Commercial Distribution

  • 00852282007013 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 5°C.
Temptime Corporation
F3
In Commercial Distribution

  • 00852282007006 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 36 months at 22.5°C.
Temptime Corporation
CT36
In Commercial Distribution

  • 00852282007136 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 22.5°C.
Temptime Corporation
CT12
In Commercial Distribution

  • 00852282007129 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 24 months at 22.5°C.
Temptime Corporation
CT24
In Commercial Distribution

  • 00852282007112 ()


  • Medical product temperature point indicator, thermochemical
Memory Staple 30 x 30-2 x 3mm / LRG
Wishbone Medical, Inc.
17624WB
Not in Commercial Distribution

  • B56217624WB0 ()


  • Orthopaedic bone staple, non-adjustable
No Description
BISCO INC.
H-403A3P
Not in Commercial Distribution

  • D757H403A3P1 ()
H-403A3P

  • Preformed dental crown, temporary
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: D3. 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.
199-2016
In Commercial Distribution

  • D77819920160 ()
199-2016

  • 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: D2. 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.
199-2015
In Commercial Distribution

  • D77819920150 ()

  • Weight: 4.5 Gram
199-2015

  • 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: C2. 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.
199-2014
In Commercial Distribution

  • D77819920140 ()
199-2014

  • 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: B4. 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.
199-2013
In Commercial Distribution

  • D77819920130 ()

  • Weight: 4.5 Gram
199-2013

  • 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: B1. 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.
199-2012
In Commercial Distribution

  • D77819920120 ()

  • Weight: 4.5 Gram
199-2012

  • 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: A4. 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.
199-2011
In Commercial Distribution

  • D77819920110 ()

  • Weight: 4.5 Gram
199-2011

  • 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: Opaque. 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.
199-2010
In Commercial Distribution

  • D77819920100 ()

  • Weight: 4.5 Gram
199-2010

  • 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: D4. 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.
199-2009
In Commercial Distribution

  • D77819920090 ()

  • Weight: 4.5 Gram
199-2009

  • 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: C3. 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.
199-2008
In Commercial Distribution

  • D77819920080 ()

  • Weight: 4.5 Gram
199-2008

  • 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: 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
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: B2. 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.
199-2005
In Commercial Distribution

  • D77819920050 ()

  • Weight: 4.5 Gram
199-2005

  • 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: A3.5. 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.
199-2004
In Commercial Distribution

  • D77819920041 ()

  • Weight: 4.5 Gram
199-2004

  • Dental composite resin
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