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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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9 Panel Drug Test Cup AMP/BAR/BZO/COC/MDMA/MTD/OPI/PCP/PPX
UCP BIOSCIENCES, INC.
U-CUP-794
In Commercial Distribution

  • 20817038022270 ()
  • 10817038022273 ()
  • 00817038022276 ()
U-CUP-794

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Vista Dental
310009
In Commercial Distribution

  • 10818207022025 ()


  • Dental impression tray, single-use
Untreated Twisted Gingival Retraction Cord, 100 inches, Size: 9/1
PASCAL COMPANY, INC.
07910
In Commercial Distribution

  • 00310866000626 ()
07910

  • Gingival retraction cord, non-medicated
Twisted Gingival Retraction Cord with Epinephrine, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07710
In Commercial Distribution

  • 00310866000541 ()
07710

  • Gingival retraction cord, medicated
Twisted Gingival Retraction cord with Aluminum Sulfate, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07610
In Commercial Distribution

  • 00310866000503 ()
07610

  • Gingival retraction cord, non-medicated
Content: 1 piece Height: 22 mm Highly translucent zirconia for single crowns to large bridges (fully anatomic structures or reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAD5501
In Commercial Distribution

  • D800ZRAD5501 ()


  • Dental bridge, ceramic
No Description
ZIRKONZAHN SRL
ZRAB1039
In Commercial Distribution

  • D800ZRAB1039 ()


  • Dental bridge, ceramic
Content: 2 pieces Height: 16 mm Translucent zirconia for single crowns to large bridges (reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAB0501
In Commercial Distribution

  • D800ZRAB0501 ()


  • Dental bridge, ceramic
For the temporary, external anchoring of sutures and prevention of suture pull through.
PRESERVATION SOLUTIONS INC
SG-9
In Commercial Distribution

  • 00810805000231 ()


  • Suture retention device
No Description
HIOSSEN, INC.
FNLHYD09
In Commercial Distribution

  • 00810126042057 ()


  • Dental implant suprastructure, temporary, preformed, single-use
The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.
TOBY ORTHOPAEDICS
NA
In Commercial Distribution

  • 00816101011957 ()
TO-LBP-122

  • Orthopaedic fixation plate, non-bioabsorbable
Tinto Carbonic Anhydrase 9 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB64170 ()
BSB 6417

  • Carbonic anhydrase IVD, antibody
Tinto Carbonic Anhydrase 9 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB64160 ()
BSB 6416

  • Carbonic anhydrase IVD, antibody
Carbonic Anhydrase 9 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB64150 ()
BSB 6415

  • Carbonic anhydrase IVD, antibody
No Description
Trilliant Surgical, LLC
300-62-002
In Commercial Distribution

  • 00812926025506 ()

  • 9 Hole VL Tibia Plate


  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Coil for G-scan Brio Service
ESAOTE SPA
131000401
In Commercial Distribution

  • 08056304452887 ()


  • MRI system coil, radio-frequency
No Description
ESAOTE SPA
9102693101
In Commercial Distribution

  • 08056304452832 ()


  • MRI system coil, radio-frequency
Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The Fenestrated model is made for use with a voice prosthesis. The Fenestrated model can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7641
In Commercial Distribution

  • 07331791002533 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 55 Millimeter
7641

  • Tracheostomy tube, non-reinforced, non-customized, reusable
Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The Fenestrated model is made for use with a voice prosthesis. The Fenestrated model can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7640
In Commercial Distribution

  • 07331791002519 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 36 Millimeter
7640

  • Tracheostomy tube, non-reinforced, non-customized, reusable
No Description
Bird & Cronin, LLC
90001762
In Commercial Distribution

  • 50610570190558 ()
  • 00610570190553 ()


  • Abdominal binder, single-use
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