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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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Coldpac Denture and Repair Acrylic Kit. Contains one 16 oz. powder (Medium Fibered) and one 8 oz. liquid.
BIRD-X, INC.
DK1603
In Commercial Distribution

  • 00706069343361 ()

  • Total Volume: 8.0 Fluid Ounce
  • Weight: 1 Pound


  • Dental appliance fabrication material, resin
Coldpac Denture and Repair Acrylic Kit. Contains one 16 oz. powder (Light Fibered) and one 8 oz. liquid.
BIRD-X, INC.
DK1601
In Commercial Distribution

  • 00706069343163 ()

  • Weight: 1 Pound
  • Total Volume: 8.0 Fluid Ounce


  • Dental appliance fabrication material, resin
Bindex measurement system kit. Packed in a case containing one Bindex BI-2 device and one Bindex Measure BI-41.
Bone Index Finland Oy
v4 (w/o Gel)
In Commercial Distribution

  • 06430065790068 ()


  • Bone absorptiometric ultrasound system
Bindex measurement system kit. Packed in a case containing one Bindex BI-2 device and one Bindex Measure BI-41.
Bone Index Finland Oy
v3 (w/o Gel)
In Commercial Distribution

  • 06430065790051 ()


  • Bone absorptiometric ultrasound system
Bindex measurement system kit. Packed in a case containing one Bindex BI-2 device and one Bindex Measure BI-41.
Bone Index Finland Oy
v2 (w/o Gel)
In Commercial Distribution

  • 06430065790044 ()


  • Bone absorptiometric ultrasound system
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
Integra® Jarit® Cottle Mallet, 7", 1-1/8"Diameter, Black Aluminum Handle, One Flat, One Round Face
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
410335
In Commercial Distribution

  • M2744103351 ()
  • 10381780456483 ()
410-335

  • Surgical mallet
Tardy rasp, 8 1/2'', double-ended, one flat and one convex blade, fine and coarse teeth, flat handle
AMBLER SURGICAL CORP.
Tardy rasp
In Commercial Distribution

  • 00190660130589 ()
69-875

  • Nasal file/rasp
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
Castroviejo lacrimal dilator, 5 3/4'', double-ended, one needle-point end and one medium-taper end, round, knurled handle, titanium
AMBLER SURGICAL CORP.
Castroviejo lacrimal dilator
In Commercial Distribution

  • 00190660029555 ()
9889T

  • Lacrimal dilator, reusable
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