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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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SKLAR CORPORATION
91-2695
In Commercial Distribution

  • 10649111257575 ()


  • Gynaecological grasping forceps
Stationary Cabinet x-ray system with 15x15 cm imager used to provide two and three dimensional digital x-ray images of harvested specimens from various anatomical regions.
FAXITRON BIOPTICS, LLC
VisionCT 15x15
In Commercial Distribution

  • 00857069006227 ()


  • Stationary specimen x-ray system, digital
MI Paste Plus™ 10 tubes (40g each) of MI Paste Plus Assorted pack, has two tubes of each flavor (melon, mint, strawberry, tutti-frutti & vanilla)
Gc America Inc.
422614
In Commercial Distribution

  • D6584226142 ()
  • D6584226141 ()
422614

  • Dental coating, tooth-desensitizing
Non-Ratcheted finger ring device commonly used for debridement and removing debris from the ear.
SKLAR CORPORATION
67-1020
In Commercial Distribution

  • 10649111294235 ()


  • ENT forceps
DOUBLE PRONG FCPS MEDIUM 50CM
TELEFLEX INCORPORATED
IPN007862
In Commercial Distribution

  • 04026704530861 ()
  • 24026704531398 ()

  • Length: 50 Centimeter
506252

  • ENT forceps
The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Relja Innovations LLC
RI-2427-C
In Commercial Distribution

  • 00860005968800 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
4.0MM CANNULATED SCREW, SQUARE DRIVER, LENGTH 60
Safetyfix Medical Technologies
4.0MM CANNULATED SCREW, SQUARE DRIVER, LENGTH 60
In Commercial Distribution

  • 00853785008576 ()

  • Length: 60 Millimeter
  • Outer Diameter: 4.0 Millimeter
22761-0021-2.7-60

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
4.0MM CANNULATED SCREW, SQUARE DRIVER, LENGTH 58
Safetyfix Medical Technologies
4.0MM CANNULATED SCREW, SQUARE DRIVER, LENGTH 58
In Commercial Distribution

  • 00853785008569 ()

  • Outer Diameter: 4.0 Millimeter
  • Length: 58 Millimeter
22761-0021-2.7-58

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
4.0MM CANNULATED SCREW, SQUARE DRIVER, LENGTH 56
Safetyfix Medical Technologies
4.0MM CANNULATED SCREW, SQUARE DRIVER, LENGTH 56
In Commercial Distribution

  • 00853785008552 ()

  • Length: 56 Millimeter
  • Outer Diameter: 4.0 Millimeter
22761-0021-2.7-56

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
4.0MM CANNULATED SCREW, SQUARE DRIVER, LENGTH 54
Safetyfix Medical Technologies
4.0MM CANNULATED SCREW, SQUARE DRIVER, LENGTH 54
In Commercial Distribution

  • 00853785008545 ()

  • Outer Diameter: 4.0 Millimeter
  • Length: 54 Millimeter
22761-0021-2.7-54

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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