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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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Integra® Miltex® - 10381780427193

Integra® Miltex® Putti Bone Rasp, 10-1/2", Double-Ended, Flat Blades, One Curved Up, One Curved Sideways
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
27-700
In Commercial Distribution

  • H834277000 ()
  • 10381780427193 ()

  • 10-1/2"
27-700

  • Bone file/rasp, manual, reusable

Gyrus ACMI - 00821925042391

EPISTAXIS BALOON CATHETER KIT. CONTAINS: ONE CATHETER, ONE 10 CC SYRINGE AND TWO 4 x 4". GAUZE PADS
Gyrus ACMI, LLC
890912
In Commercial Distribution

  • 00821925022379 ()
  • 00821925042391 ()


  • Intranasal splint, non-bioabsorbable, animal-derived

HEALICOIL - 00885554032116

HEALICOIL PK 5.5 MM SUTURE ANCHOR WITH ONE ULTRATAPE SUTURE COBRAID BLUE AND ONE ULTRABRAID SUTURE No.2
Smith & Nephew, Inc.
72203984
In Commercial Distribution

  • 00885554032116 ()
72203984

  • Tendon/ligament bone anchor, non-bioabsorbable

HEALICOIL REGENESORB - 00885554031393

HEALICOIL REGENESORB 4.75 MM SUTURE ANCHOR WITH ONE ULTRATAPE SUTURE COBRAID BLUE AND ONE ULTRABRAID SUTURE No.2
Smith & Nephew, Inc.
72203697
In Commercial Distribution

  • 00885554031393 ()
72203697

  • Tendon/ligament bone anchor, bioabsorbable

Accessories - 10816203023435

Two male luers to one spike port and one female luer with 20cm SCD tubing with pinch clamps.
ORIGEN BIOMEDICAL, INC.
40-PF-2M
In Commercial Distribution

  • 20816203023432 ()
  • 10816203023435 ()


  • Blood transfer set

Female to Female Adapter - 10816203022322

One female luer to one male luer with 12cm DMSO resistant tubing, singly aseptically pouched, case of 50
ORIGEN BIOMEDICAL, INC.
F-M12
Not in Commercial Distribution

  • 10816203022322 ()
  • 20816203022329 ()


  • Blood transfer set

Skytron DoVera - 10841736113858

Light, Surgical, consiting of one to three light heads or one to two light heads and monitor arm. One or two light heads may utilize a camera or one light head my utilize a camera with a monitor arm.
SKYTRON LLC
DM520
In Commercial Distribution

  • 10841736113858 ()


  • Operating room light system

Dunlee Sentinelle - 00884838120037

VS BREAST 1.5T 8CH TT FULL SET w PACKAGNG consists of an interface box, one medial coil element, 3Ch right and left coil elements, 1Ch right and left coil elmements, one medial plug, one patient support assembly, one box of 10 sterilized biopsy grids, and one fiducial marker block grid assembly.
Philips Medical Systems Nederland B.V.
9896-032-17241
In Commercial Distribution

  • 00884838120037 ()


  • MRI system coil, radio-frequency

Dunlee Sentinelle - 00884838119963

VS BRST 3T 8CH TT FULL SET w SHALLOW RSR consists of one medial coil element, one interface box, 1Ch left and right coil elements, one medial plug, 3Ch left and right coil elements, patient support, one box of 10 sterile biopsy grids and one fiducial marker grid block assembly.
Philips Medical Systems Nederland B.V.
989603217261
In Commercial Distribution

  • 00884838119963 ()


  • MRI system coil, radio-frequency

Cavitron® - D003815131

Bellissima® FOCUSED SPRAY® slimLINE® Ultrasonic Insert 30K (B) FSI®-SLI® 3-Pack. Contains: one 30K FSI-SLI 10R, one 30K FSI-SLI 10L, one 30K FSI-SLI 10S
Dentsply Professional
81513
Not in Commercial Distribution

  • D003815131 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
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