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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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Novel - 00811801034978

CERVICAL TRIAL, 5 HEIGHT, 14 WIDTH, 12 DEPTH, 5°
ALPHATEC SPINE, INC.
CI-10169-005
In Commercial Distribution

  • 00811801034978 ()

  • Height: 5 Millimeter
  • Angle: 5 degree
  • Depth: 12 Millimeter
  • Width: 14 Millimeter


  • Spinal implant trial

Novel - 00811801034466

5 MM TRIAL, 12 X 14 MM, 5 DEGREE
ALPHATEC SPINE, INC.
CI-10317-10-05
In Commercial Distribution

  • 00811801034466 ()


  • Spinal implant trial

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

Budde® - 10381780537762

Budde® 13/64" – 5/8" x 5" Tapered
INTEGRA LIFESCIENCES CORPORATION
438A1154C
In Commercial Distribution


  • 5" Length x 0.5" Width x 0.05" Height
438A1154C

  • Neurosurgical retraction system, brain

Budde® - 10381780253204

Budde® 13/64” – 5/8” x 5” Tapered
INTEGRA LIFESCIENCES CORPORATION
438A1154C
In Commercial Distribution

  • M268438A1154C1 ()
  • 10381780253204 ()

  • 5" Length x 0.5" Width x 0.05" Height
438A1154C

  • Neurosurgical retraction system, brain

Bioplate® - M384815742US1

Self-Drilling Screw - Low-Profile - Ø1.5mm x 5 mm [5 PK]
Bioplate, Inc.
81-5742[US]
In Commercial Distribution

  • M384815742US1 ()
  • M384815742US0 ()

  • Length: 5 Millimeter
81-5742[US]

  • Craniofacial bone screw, non-bioabsorbable

Bioplate® - M3848157421

Self-Drilling Screw - Low-Profile - Ø1.5mm x 5 mm [5 PK]
Bioplate, Inc.
81-5742
In Commercial Distribution

  • M3848157421 ()
  • M3848157420 ()

  • Length: 5 Millimeter
81-5742

  • Craniofacial bone screw, non-bioabsorbable

Bioplate® - M384813043US1

Emergency Screw - Ø2.3 mm x 5 mm [5 PK]
Bioplate, Inc.
81-3043[US]
In Commercial Distribution

  • M384813043US1 ()
  • M384813043US0 ()

  • Length: 5 Millimeter
81-3043[US]

  • Craniofacial bone screw, non-bioabsorbable

Bioplate® - M3848130431

Emergency Screw - Ø2.3 mm x 5 mm [5 PK]
Bioplate, Inc.
81-3043
In Commercial Distribution

  • M3848130431 ()
  • M3848130430 ()

  • Length: 5 Millimeter
  • Length: 6 Millimeter
81-3043

  • Craniofacial bone screw, non-bioabsorbable

Bioplate® - M384812077US1

Self-Drilling Screw - Ø1.9 mm x 5 mm [5 PK]
Bioplate, Inc.
81-2077[US]
In Commercial Distribution

  • M384812077US1 ()
  • M384812077US0 ()

  • Length: 5 Millimeter
81-2077[US]

  • Craniofacial bone screw, non-bioabsorbable
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