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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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Flex - 00851906007712

Flex Disc 24 count Horizontal Bag
The Flex Company
10150
In Commercial Distribution

  • 20851906007716 ()
  • 00851906007712 ()
  • 30851906007713 ()
  • 00851906007040 ()


  • Menstrual cup/disc, non-latex, single-use

Flex - 00851906007088

Flex 24 count bag (English only)
The Flex Company
Flex 24 count bag (English only)
In Commercial Distribution

  • 10851906007085 ()
  • 00851906007088 ()
  • 00851906007040 ()


  • Menstrual cup/disc, non-latex, single-use

Band Assemblies - 00190707133443

Elite022 LR6 Double BuccalTube Epic 24
ORTHO ORGANIZERS, INC.
900-12306E-24
In Commercial Distribution

  • 00190707133443 ()


  • Orthodontic metal band

Opti-Handles - 00841962119900

Opti-Handles, 60cm (24") set of 2
Qfix
RT-4457
In Commercial Distribution

  • 00841962119900 ()
RT-4457

  • Indexed-immobilization patient positioning system

Pryor - 00007618875235

4/24/1/2SS, 4 Hook
PRYOR PRODUCTS
107-SST
Not in Commercial Distribution

  • 00007618875235 ()
107-SST

  • Freestanding/bed-attached intravenous pole

Insure® Lite - EDEL6051020

Insure® Lite Yellow-Red Light, Syringe 3g
DeltaMed GmbH
605102
In Commercial Distribution

605102

  • Dental composite resin

Insure® Lite - EDEL6051010

Insure® Lite Clear, Syringe 3g
DeltaMed GmbH
605101
In Commercial Distribution

605101

  • Dental composite resin

Prevue® - EDEL6041070

Prevue® Pink Opaque, Syringe 2.5g
DeltaMed GmbH
604107
In Commercial Distribution

604107

  • Dental composite resin

Prevue® - EDEL6041060

Prevue® Yellow Opaque, Syringe 2.5g
DeltaMed GmbH
604106
In Commercial Distribution

604106

  • Dental composite resin

Prevue® - EDEL6041050

Prevue® White Opaque, Syringe 2.5g
DeltaMed GmbH
604105
In Commercial Distribution

604105

  • Dental composite resin

Prevue® - EDEL6041040

Prevue® Grey Light, Syringe 2.5g
DeltaMed GmbH
604104
In Commercial Distribution

604104

  • Dental composite resin

Prevue® - EDEL6041030

Prevue® Yellow-Red Universal, Syringe 2.5g
DeltaMed GmbH
604103
In Commercial Distribution

604103

  • Dental composite resin

Prevue® - EDEL6041020

Prevue® Yellow-Red Light, Syringe 2.5g
DeltaMed GmbH
604102
In Commercial Distribution

604102

  • Dental composite resin

Prevue® - EDEL6041010

Prevue® Clear, Syringe 2.5g
DeltaMed GmbH
604101
In Commercial Distribution

604101

  • Dental composite resin

Creative Color® Opaquer - EDEL603A350

Creative Color® Opaquer A3.5, Syringe 2.5g
DeltaMed GmbH
603A35
In Commercial Distribution

603A35

  • Dental composite resin

Creative Color® Opaquer - EDEL6031WO0

Creative Color® Opaquer White, Syringe 2.5g
DeltaMed GmbH
6031WO
In Commercial Distribution

6031WO

  • Dental composite resin

Creative Color® Pink Opaque™ - EDEL6031PO0

Creative Color® Pink Opaque™, Syringe 2.5g
DeltaMed GmbH
6031PO
In Commercial Distribution

6031PO

  • Dental composite resin

Creative Color® Tint - EDEL6031LB0

Creative Color® Tint Light Brown, Syringe 2.5g
DeltaMed GmbH
6031LB
In Commercial Distribution

6031LB

  • Dental composite resin

Creative Color® Tint - EDEL6031HY0

Creative Color® Tint Honey Yellow, Syringe 2.5g
DeltaMed GmbH
6031HY
In Commercial Distribution

6031HY

  • Dental composite resin

Creative Color® Tint - EDEL6031DB0

Creative Color® Tint Dark Brown, Syringe 2.5g
DeltaMed GmbH
6031DB
In Commercial Distribution

6031DB

  • Dental composite resin

Creative Color® Opaquer - EDEL6031D30

Creative Color® Opaquer D3-D4, Syringe 2.5g
DeltaMed GmbH
6031D3
In Commercial Distribution

6031D3

  • Dental composite resin

Creative Color® Opaquer - EDEL6031C40

Creative Color® Opaquer C4, Syringe 2.5g
DeltaMed GmbH
6031C4
In Commercial Distribution

6031C4

  • Dental composite resin

Creative Color® Opaquer - EDEL6031C20

Creative Color® Opaquer C2-C3, Syringe 2.5g
DeltaMed GmbH
6031C2
In Commercial Distribution

6031C2

  • Dental composite resin

SCOTT'S SELECT FLOWABLE COMP 4-2gm (D3) - D77819950161

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 COMP 4-2gm (C4) - D77819950141

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 COMP 4-2gm (C2) - D77819950131

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 COMP 4-2gm (B1) - D77819950111

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 COMP 4-2gm (OPAQ) - D77819950101

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 COMP 4-2gm (C3) - D77819950091

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 COMP 4-2gm (C1) - D77819950081

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 COMP 4-2gm (B3) - D77819950071

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 COMP 4-2gm (B2) - D77819950061

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 COMP 4-2gm (A4) - D77819950051

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 COMP 4-2gm (A3.5) - D77819950041

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 COMP 4-2gm (A3 - D77819950031

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 COMP 4-2gm (A2) - D77819950021

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 COMP 4-2gm (A1) - D77819950011

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

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (D2) - D77819930150

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: D2. 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.
199-3015
In Commercial Distribution

  • D77819930150 ()

  • Weight: 4.5 Gram
199-3015

  • Dental composite resin

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (C2) - D77819930140

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: C2. 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.
199-3014
In Commercial Distribution

  • D77819930140 ()

  • Weight: 4.5 Gram
199-3014

  • Dental composite resin

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (B4) - D77819930130

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: B4. 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.
199-3013
In Commercial Distribution

  • D77819930130 ()

  • Weight: 4.5 Gram
199-3013

  • Dental composite resin
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