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
MAXILL, INC.
53810
In Commercial Distribution

  • 00060705538109 ()
  • 90060705538102 ()


  • Silicone dental impression material
2 - Packaged 25' O2 Tubing (0025), 6 - Packaged Soft Cannula with 7' Tubing (0556), 1 - Swivel Connector (0590), 1 - Barbed Connector (40076).
WESTMED, INC.
0713
In Commercial Distribution

  • 10709078003605 ()
  • 00709078003608 ()


  • Nasal oxygen cannula, basic
  • Oxygen administration kit
  • Oxygen administration tubing
1 - Packaged Swivel Connector (0590), 2 - Brass Washers (80141), 2 - Packaged 25' O2 Tubing (0025), 6 - Packaged Soft Cannula with 7' Tubing (0556), 2 - Barbed Connector (40076), 1 - Cylinder Wrench (20014), 4 - Packaged Soft Cannula 4' Tubing (0194).
WESTMED, INC.
0712
In Commercial Distribution

  • 10709078003599 ()
  • 00709078003592 ()


  • Oxygen administration tubing
  • Nasal oxygen cannula, basic
  • Oxygen administration kit
No Description
BLINK MEDICAL LIMITED
HR704
In Commercial Distribution

  • 05060480401075 ()
  • 05060480406582 ()


  • Self-retaining surgical retractor, single-use
West Lacrimal Cannula, 23ga, Blunt Tip, Bottom Port, Gently Curved Shaft, Polished Finish, Excluding Hub Overall Length 1-7/8" (48mm)
Med Saver, Inc.
5-5529
In Commercial Distribution

  • 00194613065157 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
No Description
Zero G Eyewear
West LA Midnight Blue UF
In Commercial Distribution

  • 00840322902145 ()


  • Prescription spectacles
No Description
Zero G Eyewear
West LA Green Glass UF
In Commercial Distribution

  • 00840322902114 ()


  • Prescription spectacles
No Description
Terumo Cardiovascular Systems Corporation
CXOT281
In Commercial Distribution

  • 50699753451013 ()
  • 00699753451018 ()


  • Extracorporeal membrane oxygenator
No Description
Terumo Cardiovascular Systems Corporation
CXOT281
In Commercial Distribution

  • 50699753450917 ()
  • 00699753450912 ()


  • Extracorporeal membrane oxygenator
No Description
Zero G Eyewear
West LA Black Navy Tort UF
In Commercial Distribution

  • 00840322902091 ()


  • Prescription spectacles
No Description
W.H. Holden, Inc.
10-5416HD
In Commercial Distribution

  • D928105416HD0 ()


  • Periosteal elevator, reusable
Procleix WNV/Babesia Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Babesia microti and West Nile Virus (WNV) with the Procleix Babesia Assay and Procleix WNV Assay respectively performed on the Procleix Panther System.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Babesia Positive Control
In Commercial Distribution

  • 00850032683050 ()


  • Multiple Babesia species nucleic acid IVD, control
Procleix WNV/Babesia Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Babesia microti and West Nile Virus (WNV) with the Procleix Babesia Assay and Procleix WNV Assay respectively performed on the Procleix Panther System.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
WNV/Babesia Negative Control
In Commercial Distribution

  • 00850032683043 ()


  • PCR/NAT negative control IVD
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
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
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
PRE SCREWDRIVER X0703482 HNDL 1 INCH PHN
MEDTRONIC SOFAMOR DANEK, INC.
X0703482
In Commercial Distribution

  • 00721902947650 ()


  • Orthopaedic implant driver
DRIVER 7480320 NUT REMOVAL
MEDTRONIC SOFAMOR DANEK, INC.
7480320
In Commercial Distribution

  • 00721902925313 ()


  • Surgical drill guide, reusable
INSTRUMENT 7480118 SCREWDRIVER T20
MEDTRONIC SOFAMOR DANEK, INC.
7480118
In Commercial Distribution

  • 00721902912641 ()


  • Surgical screwdriver, reusable
INSTRUMENT 7480325 PRVSNL DRIVER 8MM HEX
MEDTRONIC SOFAMOR DANEK, INC.
7480325
In Commercial Distribution

  • 00721902908101 ()


  • Surgical drill guide, reusable
FLEXMESH 8001533-6 1.5 LARGE RIGID
MEDTRONIC PS MEDICAL, INC.
8001533-6
In Commercial Distribution

  • 00721902858796 ()

  • Length: 148.0 Millimeter
  • Height: 0.6 Millimeter
  • Width: 148.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001531-6 148X148MM 0.6MM CP1
MEDTRONIC PS MEDICAL, INC.
8001531-6
In Commercial Distribution

  • 00721902858789 ()

  • Width: 148.0 Millimeter
  • Height: 0.6 Millimeter
  • Length: 148.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001523-6 1.5 MEDIUM RIGID
MEDTRONIC PS MEDICAL, INC.
8001523-6
In Commercial Distribution

  • 00721902858765 ()

  • Width: 77.0 Millimeter
  • Length: 113.0 Millimeter
  • Height: 0.6 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001521-6 1.5 MEDIUM STANDARD
MEDTRONIC PS MEDICAL, INC.
8001521-6
In Commercial Distribution

  • 00721902858758 ()

  • Length: 113.0 Millimeter
  • Width: 77.0 Millimeter
  • Height: 0.6 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001521-3 1.5 MEDIUM THIN
MEDTRONIC PS MEDICAL, INC.
8001521-3
In Commercial Distribution

  • 00721902858741 ()

  • Length: 113.0 Millimeter
  • Height: 0.3 Millimeter
  • Width: 77.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001511-6 1.5 SML STANDARD
MEDTRONIC PS MEDICAL, INC.
8001511-6
In Commercial Distribution

  • 00721902858727 ()

  • Height: 0.6 Millimeter
  • Width: 50.0 Millimeter
  • Length: 56.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
INSTRUMENT 7480119 MAS SCRDRV THUMBWEEL
MEDTRONIC SOFAMOR DANEK, INC.
7480119
In Commercial Distribution

  • 00721902855429 ()


  • Surgical screwdriver, reusable
INSTRUMENT 7480131 PROVISIONAL DRV SHORT
MEDTRONIC SOFAMOR DANEK, INC.
7480131
In Commercial Distribution

  • 00721902853579 ()


  • Surgical screwdriver, reusable
M8 RATCHETING 90 PLUG DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0703007
In Commercial Distribution

  • 00721902844652 ()


  • Surgical drill guide, reusable
M8 RATCHETING 90 DEG SCWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0603016
In Commercial Distribution

  • 00721902844645 ()


  • Surgical screwdriver, reusable
ATL SCREWDRIVER T-HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0603482
In Commercial Distribution

  • 00721902822162 ()


  • Orthopaedic implant driver
HANDPIECE 8004100 BATERY POWERD DRIVER
MEDTRONIC PS MEDICAL, INC.
8004100
In Commercial Distribution

  • 00721902805868 ()


  • Bone/joint surgical power tool motor, electric
TRAY 8004200 BATTERY POWERED DRIVER
MEDTRONIC PS MEDICAL, INC.
8004200
In Commercial Distribution

  • 00721902805509 ()


  • Instrument tray, reusable
CDH PLUG DRIVER-T25-U/V JOINT
MEDTRONIC SOFAMOR DANEK, INC.
X0403009
In Commercial Distribution

  • 00721902794148 ()


  • Orthopaedic implant driver
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