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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No Description
FLEXICARE MEDICAL LIMITED
038-972-055U
In Commercial Distribution

  • 05055788728023 ()


  • Basic endotracheal tube, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-972-060U
In Commercial Distribution

  • 05055788727972 ()


  • Basic endotracheal tube, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-972-065U
In Commercial Distribution

  • 05055788727927 ()


  • Basic endotracheal tube, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-972-070U
In Commercial Distribution

  • 05055788727873 ()


  • Basic endotracheal tube, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-972-075U
In Commercial Distribution

  • 05055788727828 ()


  • Basic endotracheal tube, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-972-080U
In Commercial Distribution

  • 05055788727774 ()


  • Basic endotracheal tube, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-972-085U
In Commercial Distribution

  • 05055788727729 ()


  • Basic endotracheal tube, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-972-090U
In Commercial Distribution

  • 05055788727682 ()


  • Basic endotracheal tube, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-982-080U
In Commercial Distribution

  • 05055788707929 ()


  • Basic endotracheal tube, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-982-090U
In Commercial Distribution

  • 05055788707905 ()


  • Basic endotracheal tube, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-982-075U
In Commercial Distribution

  • 05055788707783 ()


  • Basic endotracheal tube, single-use
Doll Teether~The Doll Teether is a multi-textured toy and provides your child different surfaces to feel and touch. It also enhances your baby's sense of security and comfort. Distributed by MidwoodBrands LLC 10611 Monroe Road, Matthews, North Carolina 28105 USA. MidwoodBrands LLC 0322510458060617
Regent Baby Products Corp.
SKU 1600132
In Commercial Distribution

  • 00032251045806 ()


  • Teething device, fluid-filled
Connex Central Station includes CPU with Connex Server Application. Software, Windows desktop operating system, SQL Express, and anti-virussoftware pre-loaded; 24" Display Monitor; Power cord compatible with specs in North/South America; and Keyboard.
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094195439 ()
105736

  • Centralized patient monitor
R-SI-LINE ® MONO S SCAN is an universal, really direct scannable one-phase precision impression material based on vinyl polysiloxane (VPS) recommended for the CAD/CAM/CIM-technology. The white-lilac A-silicone is indicated for functional impressions and one-phase impressions like impressions for crowns, bridges, inlays, partial and complete dentures and denture repairs and impressions for prosthetic restorations. R-SI-LINE ® MONO S SCAN guarantees a precise detail reproduction due to its superhydophilic consistency, which ensures an excellent wetting of the tooth structure. It provides an excellent scannability and a very good Snap-Set. The product is available in standard 50 ml auto-mixing cartridges plus 12 mixing cannulas. It can be dispensed with a commercial dispenser.
R-Dental Dentalerzeugnisse GmbH
MOK0475
In Commercial Distribution

  • ERDEMOK04751 ()
  • CARTRIDGES2 ()
MOK0475

  • Silicone dental impression material
Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSP2-L
In Commercial Distribution

  • 08809186549455 ()

  • 12mm X 25mm


  • Dental bone matrix implant, animal-derived
Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSP1-S
In Commercial Distribution

  • 08809186549448 ()

  • 8mm X 18mm


  • Dental bone matrix implant, animal-derived
Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSB2-L
In Commercial Distribution

  • 08809186549431 ()

  • 8mm X 7mm X 9mm


  • Dental bone matrix implant, animal-derived
Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSB1-S
In Commercial Distribution

  • 08809186549424 ()

  • 6mm X 5mm X 7mm


  • Dental bone matrix implant, animal-derived
METAL-BITE ® GOLD is an universal and scannable registration material on vinyl polysiloxane base (addition curing, VPS). METAL-BITE ® GOLD is extremely fast, hard and thixotropic. It is easy to trim, very suitable for cutting and contouring. The material has no taste at all, is radiopaque and offers an excellent dimension stability. Further on METAL-BITE ® GOLD is optimzed for CEREC 3D, the contrast of METAL-BITE ® GOLD has been increased and offers brilliant antagonist data. It is predestined for dynamic registrations according to FGP methods and classical facebow registrations. The registrations can then be scanned. METAL-BITE ® GOLD was introduced in 2005. METAL-BITE ® GOLD is marketed in many countries worldwide. The product is available in standard 50 ml auto-mixing cartridges plus 12 mixing cannulas and can be dispensed with a commercial dispenser.
R-Dental Dentalerzeugnisse GmbH
MBK0750
In Commercial Distribution

  • ERDEMBK07501 ()
  • CARTRIDGES2 ()
MBK0750

  • Silicone dental impression material
METAL-BITE ® Blue is an universal and scannable registration material on vinyl polysiloxane base (addition curing, VPS). METAL-BITE ® Blue is extremely fast, hard and thixotropic. It is easy to trim, very suitable for cutting and contouring. The material has no taste at all, is radiopaque and offers an excellent dimension stability. Further on METAL-BITE ® Blue is predestined for static hicp and antagonist registrations, dynamic registrations according to FGP methods and classical facebow registrations. The registrations can then be scanned. METAL-BITE ® Blue was introduced with and for SIRONA CEREC systems (especially CEREC AC Bluecam) in early 2009. The Dental Advisor compared in its "Editors’ Note" METAL-BITE ® Blue with the classical METAL-BITE. METAL-BITE ® Blue is marketed worldwide. The product is available in standard 50 ml auto-mixing cartridges plus 12 mixing cannulas and can be dispensed with a commercial dispenser.
R-Dental Dentalerzeugnisse GmbH
MBK0475
In Commercial Distribution

  • ERDEMBK04751 ()
  • CARTRIDGES2 ()
MBK0475

  • Silicone dental impression material
Straumann® Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Straumann® Regenomer® is manufactured in three types, Straumann® Regenomer® Syringe (sheet shape in syringe and blister), Straumann® Regenomer® Plug (bullet shape in blister), and Straumann® Regenomer® Block (block shape in blister). Straumann® Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSB2-L
In Commercial Distribution

  • 08809186542067 ()

  • 8mm X 7mm X 9mm


  • Dental bone matrix implant, animal-derived
Straumann® Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Straumann® Regenomer® is manufactured in three types,Straumann® Regenomer® Syringe (sheet shape in syringe and blister), Straumann® Regenomer® Plug (bullet shape in blister), and Straumann® Regenomer® Block (block shape in blister). Straumann® Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSB1-S
In Commercial Distribution

  • 08809186542050 ()

  • 6mm X 5mm X 7mm


  • Dental bone matrix implant, animal-derived
Straumann® Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Straumann® Regenomer® is manufactured in three types, Straumann® Regenomer® Syringe (sheet shape in syringe and blister), Straumann® Regenomer® Plug (bullet shape in blister), and Straumann® Regenomer® Block (block shape in blister). Straumann® Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSP2-L
In Commercial Distribution

  • 08809186542043 ()

  • 12mm X 25mm


  • Dental bone matrix implant, animal-derived
Straumann® Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Straumann® Regenomer® is manufactured in three types, Straumann® Regenomer® Syringe (sheet shape in syringe and blister), Straumann® Regenomer® Plug (bullet shape in blister), and Straumann® Regenomer® Block (block shape in blister). Straumann® Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSP1-S
In Commercial Distribution

  • 08809186542036 ()

  • 8mm X 18mm


  • Dental bone matrix implant, animal-derived
DRIVER 7480113 MAS LEGACY 5.5
MEDTRONIC SOFAMOR DANEK, INC.
7480113
In Commercial Distribution

  • 00721902861468 ()


  • Orthopaedic implant driver
FLEXMESH 8002233-6 2.2 LARGE RIGID
MEDTRONIC PS MEDICAL, INC.
8002233-6
In Commercial Distribution

  • 00721902858826 ()

  • Height: 0.6 Millimeter
  • Width: 154.0 Millimeter
  • Length: 154.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001511-3 1.5 SML THIN
MEDTRONIC PS MEDICAL, INC.
8001511-3
In Commercial Distribution

  • 00721902858710 ()

  • Width: 50.0 Millimeter
  • Length: 56.0 Millimeter
  • Height: 0.3 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
INSTRUMENT 7480156 NON BRKOFF PLUG STRTR
MEDTRONIC SOFAMOR DANEK, INC.
7480156
In Commercial Distribution

  • 00721902857607 ()


  • Surgical screwdriver, reusable
INSTRUMENT 7480147 DRV QUICK CONNECT T27
MEDTRONIC SOFAMOR DANEK, INC.
7480147
In Commercial Distribution

  • 00721902857089 ()


  • Surgical screwdriver, reusable
INSTRUMENT 7480114 TAPERED HEX SCRWDRVER
MEDTRONIC SOFAMOR DANEK, INC.
7480114
In Commercial Distribution

  • 00721902856976 ()


  • Surgical screwdriver, reusable
INSTRUMENT 7480144 DRV BREAK OFF 6.35 HX
MEDTRONIC SOFAMOR DANEK, INC.
7480144
In Commercial Distribution

  • 00721902853586 ()


  • Surgical screwdriver, reusable
INSTRUMENT 9339042 TORQUE LIMITING DRIVR
MEDTRONIC SOFAMOR DANEK, INC.
9339042
In Commercial Distribution

  • 00721902813825 ()


  • Surgical screwdriver, reusable
HEX DRIVER X1103002 WITH AO CHUCK 2.5MM
MEDTRONIC SOFAMOR DANEK, INC.
X1103002
In Commercial Distribution

  • 00721902999093 ()


  • Orthopaedic implant driver
SQUARE DRIVE SHAFT 2.5MM HEX
MEDTRONIC SOFAMOR DANEK, INC.
X1003022
In Commercial Distribution

  • 00721902999000 ()


  • Surgical screwdriver, reusable
INSTRUMENT 9790914 REVISION INSTRUMENT
MEDTRONIC SOFAMOR DANEK, INC.
9790914
In Commercial Distribution

  • 00721902989643 ()


  • Surgical screwdriver, reusable
INSTRUMENT 9790913 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
9790913
In Commercial Distribution

  • 00721902989636 ()


  • Surgical screwdriver, reusable
INSTRUMENT 9790903 HOLDING PIN DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
9790903
In Commercial Distribution

  • 00721902989544 ()


  • Orthopaedic implant driver
INSTRUMENT 875-716 MALLET 8 IN
MEDTRONIC SOFAMOR DANEK, INC.
875-716
In Commercial Distribution

  • 00721902981197 ()

  • 8 INCH


  • Surgical mallet
INSTRUMENT 6971114 MALLET
MEDTRONIC SOFAMOR DANEK, INC.
6971114
In Commercial Distribution

  • 00721902974793 ()


  • Surgical mallet
LOCKSCREW DRIVER X0703484 1 INCH PHEN HN
MEDTRONIC SOFAMOR DANEK, INC.
X0703484
In Commercial Distribution

  • 00721902947704 ()


  • Surgical screwdriver, reusable
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