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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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Acetabular Liner, Neutral, 0 degree; Vitamin E UHMWPE; 28mm Inner Diameter, Size E
B-ONE ORTHO, CORP.
881200281E
In Commercial Distribution

  • 00843575102232 ()
881200281E

  • Non-constrained polyethylene acetabular liner
Acetabular Liner, Hooded, 10 degree; Vitamin E UHMWPE; 28mm Inner Diameter, Size E
B-ONE ORTHO, CORP.
881201281E
In Commercial Distribution

  • 00843575102393 ()
881201281E

  • Non-constrained polyethylene acetabular liner
Acetabular Liner, Neutral, 0 degree; Vitamin E UHMWPE; 32mm Inner Diameter, Size E
B-ONE ORTHO, CORP.
881200321E
In Commercial Distribution

  • 00843575102263 ()
881200321E

  • Non-constrained polyethylene acetabular liner
Manhatten E&E Suturing Forceps, .7mm, 1x2 Teeth, 6mm Tying Platform, Flat, Titanium
AURORA SURGICAL, LLC
AS7-380T
In Commercial Distribution

  • 08175700125307 ()
AS7-380T

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Shiga Toxin Direct Test Cartridge with sample prep device.
GREAT BASIN SCIENTIFIC, INC.
GBSTEC-10
In Commercial Distribution

  • B178GBSTEC102 ()
  • B178GBSTEC100 ()
GBSTEC-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Manhatten E&E Suturing Forceps, .7mm, 1x2 Teeth, 6mm Tying Platform, Flat, Stainless Steel
AURORA SURGICAL, LLC
AS7-380S
In Commercial Distribution

  • 08175700125260 ()
AS7-380S

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
No Description
REMEL EUROPE LIMITED
R30164501
In Commercial Distribution

  • 05056080501567 ()


  • Multiple meningitis-associated bacteria antigen IVD, reagent
No Description
Zimmer, Inc.
5990-15-02
In Commercial Distribution

  • 00889024001244 ()

  • Size E, Right


  • Uncoated knee femur prosthesis, metallic
No Description
Zimmer, Inc.
5990-15-01
In Commercial Distribution

  • 00889024001237 ()

  • Size E, Left


  • Uncoated knee femur prosthesis, metallic
No Description
Biomet Orthopedics, LLC
31-301123
In Commercial Distribution

  • 00887868476358 ()

  • Size E/F
31-301123

  • Femoral stem prosthesis trial
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