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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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Surgitube® - 00809958001011

5/8 in X 5 yd Tubular Gauze, White
Derma Sciences Canada Inc
105W
In Commercial Distribution

  • 00809958001011 ()

  • 5/8 in X 5 yds
  • 1.57 cm X 4.5 m
GL-105W

  • Stockinette

Symmetry Surgical - 00887482004883

Symmetry® Forceps, Jewelers, #5, 4 5/16 in
SYMMETRY SURGICAL INC.
30-6715
In Commercial Distribution

  • 00887482004883 ()

  • Length: 4.3125 Inch


  • Dressing/utility forceps, scissors-like, reusable

Simpurity - 00810040131035

Simpurity Silicone Bordered Mult-Layered Foam 5" x 5" - Each
SAFE N' SIMPLE LLC
SNS77755
In Commercial Distribution

  • 00810040131042 ()
  • 00810040131035 ()
  • 00810040131059 ()

  • Width: 5 Inch
  • Length: 5 Inch
SNS77755

  • Wound-nonadherent dressing, absorbent, non-antimicrobial

JII - 00885556774953

JOURNEY 5 IN 1 AP CUTTING BLOCK SIZE 5
Smith & Nephew, Inc.
E0016742-3
In Commercial Distribution

  • 00885556774953 ()
E0016742-3

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Symmetry Babcock - 00887482035733

Symmetry® Forceps, Babcock Baby, 5 5/8 in
SYMMETRY SURGICAL INC.
50-1014
In Commercial Distribution

  • 00887482035733 ()

  • Length: 5.625 Inch
50-1014

  • Dressing/utility forceps, tweezers-like, reusable

EVOS - 00885556458044

EVOS 2.7MM Y-PLATE 5 HOLE HEAD 5 HOLE SHAFT
Smith & Nephew, Inc.
72442778N
In Commercial Distribution

  • 00885556458044 ()
72442778N

  • Orthopaedic fixation plate, non-bioabsorbable

EVOS - 00885556456996

EVOS 2.4MM Y-PLATE 5 HOLE HEAD 5 HOLE SHAFT
Smith & Nephew, Inc.
72442482N
In Commercial Distribution

  • 00885556456996 ()
72442482N

  • Orthopaedic fixation plate, non-bioabsorbable

EVOS - 00885556441695

EVOS 2.7MM Y-PLATE 5 HOLE HEAD 5 HOLE SHAFT
Smith & Nephew, Inc.
72442778
In Commercial Distribution

  • 00885556441695 ()
72442778

  • Orthopaedic fixation plate, non-bioabsorbable

EVOS - 00885556440643

EVOS 2.4MM Y-PLATE 5 HOLE HEAD 5 HOLE SHAFT
Smith & Nephew, Inc.
72442482
In Commercial Distribution

  • 00885556440643 ()
72442482

  • Orthopaedic fixation plate, non-bioabsorbable

Microlyte Ag VET - 00860001725742

Microlyte Ag VET Matrix, 2" x 2" (5 cm x 5 cm), Box of 5
IMBED BIOSCIENCES, INC.
99000
In Commercial Distribution

  • 00860001725742 ()

  • Area/Surface Area: 25 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial

Snowden-Pencer - 70885403465552

Snowden-Pencer MIS TROCAR SEALING CAP FOR 3/3.5MM PACK OF 5 5/PK X 5
STERIS CORPORATION
TSC3-5
In Commercial Distribution

  • 70885403465552 ()
  • 10885403465550 ()
TSC35

  • Laparoscopic trocar blade, reusable

Bioplate® - M3848158870

T Plate - Low-Profile - 5 hole - 15 mm (1), Self-Drilling Screw - 4 mm (5) [5 PK]
Bioplate, Inc.
81-5887
In Commercial Distribution

  • M3848158871 ()
  • M3848158870 ()
81-5887

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable

Hypercoagulation Panel (HC) Sample Buffer - 00857573006348

The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
NANOSPHERE, INC.
30-001-001
Not in Commercial Distribution

  • 00857573006348 ()


  • Multiple coagulation factor IVD, kit, clotting

Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge - 00857573006027

The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
NANOSPHERE, INC.
20-006-001
Not in Commercial Distribution

  • 00857573006027 ()


  • Multiple coagulation factor IVD, kit, clotting

Hypercoagulation Panel (HC) Sample Buffer - 00840487101728

The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
LUMINEX CORPORATION
30-001-001
Not in Commercial Distribution

30-001-001

  • Multiple coagulation factor IVD, kit, clotting

Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge - 00840487101513

The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
LUMINEX CORPORATION
20-006-001
Not in Commercial Distribution

20-006-001

  • Multiple coagulation factor IVD, kit, clotting

SteriTec Sterilization Tape - 00814434020110

No Description
STERITEC PRODUCT MFG. CO., INC.
CI 122/.5, CI 164/.5
Not in Commercial Distribution

  • 10814434020117 ()
  • 00814434020110 ()
  • 20814434020114 ()
CI 122/.5, CI 164/.5

  • Chemical/physical sterilization process indicator

Surgical Direct - B382SD9075871000

6 5/8" Darling Popliteal Retractor Right Blade Short 1” x 2 5/8” Long, 1 5/8” x 2 5/8
Surgical Direct, Inc.
SD907587100
In Commercial Distribution

  • B382SD9075871000 ()
SD907587100

  • Self-retaining surgical retractor, reusable

OT EQUATOR TITANIUM ABUTMENT - D821OTEQUATOR030REA55

The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
REACTIVE-REPLUS DIAMETER 5 H 5
In Commercial Distribution

  • D821OTEQUATOR030REA55 ()


  • Dental implant suprastructure, permanent, preformed

OT EQUATOR TITANIUM ABUTMENT - D821OTEQUATOR030SPL55

The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
SPLINE DIAMETER 5 H 5
In Commercial Distribution

  • D821OTEQUATOR030SPL55 ()


  • Dental implant suprastructure, permanent, preformed
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