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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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No Description
Dynarex Corporation
36279
In Commercial Distribution

  • 00840117323346 ()
  • 00840117315419 ()
  • 00840117315327 ()


  • Nasopharyngeal airway, single-use
Workstation Microsoft Surface Studio 28 for Zirkonzahn Scanner
ZIRKONZAHN SRL
SYAB0510
In Commercial Distribution

  • D800SYAB0510 ()


  • Dental milling system, CAD/CAM, laboratory
This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself.
REDAX SPA
21828
In Commercial Distribution

  • 18034139293797 ()
  • 08034139293790 ()
21828

  • Pleural catheter
This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself.
REDAX SPA
20828
In Commercial Distribution

  • 18034139292851 ()
  • 08034139292854 ()
20828

  • Pleural catheter
Advocate Lancets Safety 28 Gauge 1.8 mm box of 200, sterile, for capillary blood sample, needle automatically retracts, ready to use, no loading needed, single use only
DIABETIC SUPPLY OF SUNCOAST, INC.
637
In Commercial Distribution

  • 10894046001919 ()
  • 00894046001912 ()
  • 20894046001916 ()


  • Manual blood lancing device, single-use
No Description
Eckert & Ziegler BEBIG GmbH
LAH02-28#03
Not in Commercial Distribution

  • 04049223106669 ()
LAH02-28

  • General-purpose brachytherapy system applicator, remote-afterloading
DENTAL PORCELAIN POWDER FOR CREATING DENTAL RESTORATIONS
CHAMELEON DENTAL PRODUCTS, INC
FPA128
In Commercial Distribution

  • FPA128 ()


  • Dental porcelain/ceramic restoration kit
Rapicide OPA 28 Test Strips for verifying the Concentration of RAPICIDE OPA-28 High-Level Disinfectant. (Crosstex)
MEDIVATORS INC.
ML02-0137
In Commercial Distribution

  • 00732224000541 ()
  • 10732224000548 ()
ML020137

  • Medical device disinfection solution test strip
No Description
Ventana Medical Systems, Inc.
05251621001
In Commercial Distribution

  • 07613336125571 ()
05251621001

  • Assay container IVD, single-use
No Description
BIOPRO, INC.
14091
In Commercial Distribution

  • M209140910 ()


  • Press-fit hip femur prosthesis, modular
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