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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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PIEZON - 07613353085988

System Scaling Pro Line 502-1
E.M.S. Electro Medical Systems S.A.
e
In Commercial Distribution

  • 07613353085988 ()
FS-241

  • Ultrasonic dental scaling/debridement system

PIEZON - 07613353029722

Instrument HPL3
E.M.S. Electro Medical Systems S.A.
e
In Commercial Distribution

  • 07613353029722 ()
DS-075

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal

REFLECTYS - 03760260220132

No Description
ITENA CLINICAL
E
In Commercial Distribution

  • 03760260220132 ()
SRTYS-E

  • Dental composite resin

High Density Junction Box - E - 00850011306413

Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "E" is labeled for connections to electrodes 257-320.
NEURALYNX, INC.
-E
In Commercial Distribution

  • 00850011306413 ()
31-0602-0037

  • Electrical-only medical device connection cable, reusable

Macy Catheter - 00861003000202

The Macy Catheter is intended to provide rectal access to administer liquids/medications.
HOSPI CORPORATION
E
In Commercial Distribution

  • 00861003000202 ()
MAC-1001

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Preference 2 - M555284550040

ø4.5 Triple Lead Screw Assembly, 40mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555284550040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 4.5 Millimeter
28-4550-040

  • Spinal bone screw, non-bioabsorbable

Preference 2 - M555284550030

ø4.5 Triple Lead Screw Assembly, 30mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555284550030 ()

  • Length: 30 Millimeter
  • Outer Diameter: 4.5 Millimeter
28-4550-030

  • Spinal bone screw, non-bioabsorbable

Valeo Spacer System - M555910013005

Right Cutting Cup Long Curette
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555910013005 ()
91.001.3005

  • Internal spinal fixation procedure kit, reusable

Valeo Spacer System - M555910013004

Left Cutting Cup Long Curette
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555910013004 ()
91.001.3004

  • Internal spinal fixation procedure kit, reusable

Preference 2 - M555286550060

ø6.5 Triple Lead Screw Assembly, 60mm
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555286550060 ()

  • Length: 60 Millimeter
  • Outer Diameter: 6.5 Millimeter
28-6550-060

  • Spinal bone screw, non-bioabsorbable
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