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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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Norfentanyl DAU Calibrator, Cutoff Calibrator - B07603130

5 mL/bottle. Concentration: 5 ng/mL of Norfentanyl.
LIN-ZHI INTERNATIONAL, INC.
0313
In Commercial Distribution

  • B07603130 ()
0313

  • Fentanyl IVD, calibrator

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

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

US IVD-Bruker Bacterial Test Standard, 5 Tubes - 10841594110099

Bacterial Test Standard, 5 tubes.
Bruker Scientific LLC
8604530
Not in Commercial Distribution

  • 10841594110099 ()
  • 00841594110092 ()
8604530

  • Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD

US IVD-Bruker Bacterial Test Standard, 5 Tubes - 04251204325642

Bacterial Test Standard, 5 tubes.
Bruker Daltonik GmbH
8604530
In Commercial Distribution

  • 04251204325642 ()
  • 04251204325758 ()
8604530

  • Brain-responsive electrical stimulation system

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

Key Surgical Suture Booties - 00849771019138

Suture Booties, Yellow, Sterile, 5 pair/pad; 5 pads/box
KEY SURGICAL, INC.
VB-1115
In Commercial Distribution

  • 10849771019135 ()
  • 00849771019138 ()

  • Lumen/Inner Diameter: .062 Inch


  • Vascular booties

Ohio - 00628101614218

5' HOSE ASMBLY USA VAC DC*OM CON 5/16"
OHIO MEDICAL, LLC
HS-05UV-DCOMC5
In Commercial Distribution

  • 00628101614218 ()
HS-05UV-DCOMC5

  • General-gas low pressure tubing, reusable
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