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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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Detector UA 10 - 10722355002221

Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed
Immunostics Company, Inc
IDU-10
In Commercial Distribution

  • 20722355002204 ()
  • 10722355002221 ()
  • 80722355002220 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

OsteoBoost, 10 cc - 00816125023400

OsteoBoost is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, OsteoBoost resorbs and is later replaced by natural bone. It provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. OsteoBoost is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
OB-10P
In Commercial Distribution

  • 00816125023400 ()
OB-10P

  • Bone matrix implant, synthetic, non-antimicrobial

Invisalign Express 10 - 00816063020042

Aligner
Align Technology, Inc.
8512
In Commercial Distribution

  • 00816063020042 ()


  • Orthodontic progressive aligner

Soprano® 10 - 07640173096559

Soprano®10 Enamel EO 100g
Cendres+Métaux SA
08057783
In Commercial Distribution

  • 07640173096559 ()
08057783

  • Dental appliance fabrication material, ceramic

Soprano® 10 - 07640173096542

Soprano®10 Enamel EO 40g
Cendres+Métaux SA
08057782
In Commercial Distribution

  • 07640173096542 ()
08057782

  • Dental appliance fabrication material, ceramic

Soprano® 10 - 07640173096535

Soprano®10 Bleach Enamel 2 100g
Cendres+Métaux SA
08057781
In Commercial Distribution

  • 07640173096535 ()
08057781

  • Dental appliance fabrication material, ceramic

Soprano® 10 - 07640173096528

Soprano®10 Bleach Enamel 2 40g
Cendres+Métaux SA
08057780
In Commercial Distribution

  • 07640173096528 ()
08057780

  • Dental appliance fabrication material, ceramic

Soprano® 10 - 07640173096511

Soprano®10 Bleach Enamel 1 100g
Cendres+Métaux SA
08057779
In Commercial Distribution

  • 07640173096511 ()
08057779

  • Dental appliance fabrication material, ceramic

Soprano® 10 - 07640173096504

Soprano®10 Bleach Enamel 1 40g
Cendres+Métaux SA
08057778
In Commercial Distribution

  • 07640173096504 ()
08057778

  • Dental appliance fabrication material, ceramic

Soprano® 10 - 07640173096498

Soprano®10 Bleach Dentine 4 100g
Cendres+Métaux SA
08057762
In Commercial Distribution

  • 07640173096498 ()
08057762

  • Dental appliance fabrication material, ceramic
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