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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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Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
NUSMILE, LTD.
NMTA2.5
In Commercial Distribution

  • 00862487000313 ()

  • Weight: 2.5 Gram
None

  • Hygroscopic dental cement
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
NUSMILE, LTD.
NMTA0.5
In Commercial Distribution

  • 00862487000306 ()

  • Weight: 0.5 Gram
None

  • Hygroscopic dental cement
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
DSC-2
In Commercial Distribution

  • 10862478000428 ()
  • 00862478000421 ()


  • Supersaturated oxygen therapy system cartridge
No Description
Collaborative Care Diagnostics LLC
2.0
In Commercial Distribution

  • 00862467000302 ()


  • Limb plethysmograph
Boston Keratoprosthesis Lucia Type 1 Aphakia with anodized Titanium back plate 7.8 mm BR (Brown ); BL (Blue)
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
L-T1A
In Commercial Distribution

  • 00862395000214 ()
L-T1A

  • Cornea prosthesis
The Boston Keratoprosthesis Click-on Type II Pseudophakia
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
CLF-TIIP
In Commercial Distribution

  • 00862395000207 ()

  • Outer Diameter: 4.5 Millimeter
CLF-TIIP

  • Cornea prosthesis
The Boston Kertoprosthesis Click-on Type II Aphakia
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
CLF-TIIA
In Commercial Distribution

  • 00862394000291 ()

  • Outer Diameter: 4.5 Millimeter
CLF-TIIA

  • Cornea prosthesis
The Boston Keratoprosthesis Click-on Type I Pseudophakia
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
CLF-IP
In Commercial Distribution

  • 00862394000284 ()

  • Outer Diameter: 5 Millimeter
CLF-IP

  • Cornea prosthesis
Boston Keratoprosthesis Click-on TypeI Aphakia
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
CLF-IA
In Commercial Distribution

  • 00862394000277 ()

  • Outer Diameter: 5 Millimeter
CLF-IA

  • Cornea prosthesis
Boston Keratoprosthesis Snap-on TypeI Titanium locking ring
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
TSR-100
In Commercial Distribution

  • 00862394000260 ()
TSR-100

  • Cornea prosthesis
Boston Keratoprosthesis Snap-on TypeI 7.0 mm Titanium Back Plate.
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
TSO-7
In Commercial Distribution

  • 00862394000253 ()

  • Outer Diameter: 7 Millimeter
TSO-7

  • Cornea prosthesis
Boston Keratoprosthesis Snap-on TypeI 8.5 mm Titanium Back Plate.
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
TSO-8.5
In Commercial Distribution

  • 00862394000246 ()

  • Outer Diameter: 8.5 Millimeter
TSO-8.5

  • Cornea prosthesis
Boston Keratoprosthesis Snap-on TypeI 7mm PMMA Back Plate
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
SO-7
In Commercial Distribution

  • 00862394000239 ()

  • Outer Diameter: 7 Millimeter
SO-7

  • Cornea prosthesis
Boston Keratoprosthesis, Snap-on TypeI. 8.5 mm PMMA Back Plate.
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
SO-8.5
In Commercial Distribution

  • 00862394000222 ()

  • Outer Diameter: 8.5 Millimeter
SO-8.5

  • Cornea prosthesis
The Boston Keratoprosthesis ( KPro) Snap-on TypeI, PMMA Aphakia
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
SOF-T15P
In Commercial Distribution

  • 00862394000215 ()

  • Outer Diameter: 5 Millimeter
SOF-T15P

  • Cornea prosthesis
The Boston Keratoprosthesis Snap-on TypeI Aphakia
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
SOF-TI5A
In Commercial Distribution

  • 00862394000208 ()

  • Outer Diameter: 5 Millimeter
SOF-TI5A

  • Cornea prosthesis
STERILE MINERVA Disposable Handpiece Contents: (1) One Single use STERILE Minerva ES Disposable Handpiece (1) One Single Use STERILE Syringe (1) One Single Use STERILE 8mm Hegar Dilator (1) One Single use NON-STERILE Desiccant (1) One NON-STERILE Handpiece Instructions For Use (1) One NON-STERILE Dilator Instructions For Use
Minerva Surgical, Inc.
MIN9770
In Commercial Distribution

  • 00862393000162 ()
  • 00862393000117 ()
MIN9770

  • Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument
MINERVA RF Controller Contents: (1) One MINERVA RF-Controller (1) One Footswitch (1) One Power Cord
Minerva Surgical, Inc.
MIN180S
In Commercial Distribution

  • 00862393000100 ()
MIN180S

  • Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument
MI5 NR, PS GB MIRUM 5
Bernafon AG
155986
In Commercial Distribution

  • 05711584057001 ()


  • Air-conduction hearing aid, receiver-in-the-ear
MI5 NR, PS GR MIRUM 5
Bernafon AG
155985
In Commercial Distribution

  • 05711584056998 ()


  • Air-conduction hearing aid, receiver-in-the-ear
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