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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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Quantum BacFuse Spinous Process Fusion Plate - 00846468002718

Dilator
Pioneer Surgical Technology, Inc.
83-DILATOR-05
Not in Commercial Distribution

83-DILATOR-05

  • Nerve/vessel retractor

Quantum BacFuse Spinous Process Fusion Plate - 00846468002701

Compressor
Pioneer Surgical Technology, Inc.
83-COMPRESSOR
Not in Commercial Distribution

  • 00846468002701 ()
83-COMPRESSOR

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002695

Instrument Case
Pioneer Surgical Technology, Inc.
83-CASE
Not in Commercial Distribution

  • 00846468002695 ()
83-CASE

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002688

Barrel Plate Inserter
Pioneer Surgical Technology, Inc.
83-B-INSERTER
Not in Commercial Distribution

83-B-INSERTER

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002886

Torque Limiting Handle
Pioneer Surgical Technology, Inc.
83-TORQHANDLE
Not in Commercial Distribution

83-TORQHANDLE

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002879

90° Sizing Distractor
Pioneer Surgical Technology, Inc.
83-THINSIZER-90
Not in Commercial Distribution

83-THINSIZER-90

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002862

Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-16
Not in Commercial Distribution

83-SLEEVE-16

  • Orthopaedic implantation sleeve, reusable

Quantum BacFuse Spinous Process Fusion Plate - 00846468002855

Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-14
Not in Commercial Distribution

83-SLEEVE-14

  • Orthopaedic implantation sleeve, reusable

VESALIUS QUANTUM adapter for disposable plates - 08034055290644

No Description
TELEA ELECTRONIC ENGEENERING SRL
4,5m
In Commercial Distribution

  • 08034055290644 ()
2505013

  • Electrosurgical cable adaptor

STARKEY - 00842318189738

No Description
Starkey Laboratories, Inc.
EVOLV AI CIC
In Commercial Distribution

  • 00842318189738 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
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