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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 PureFlow KIT CPC - Barbed Connector Adaptor - 08051160301560

No Description
SPECTRUM MEDICAL SRL
CONN-HX1
In Commercial Distribution

  • 08051160301560 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047955

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

  • 00846468047955 ()
83-TORQHANDLE

  • General internal orthopaedic fixation system implantation kit

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047948

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

  • 00846468047948 ()
83-THINSIZER-90

  • General internal orthopaedic fixation system implantation kit

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047931

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

  • 00846468047931 ()
83-SLEEVE-16

  • Orthopaedic implantation sleeve, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047924

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

  • 00846468047924 ()
83-SLEEVE-14

  • Orthopaedic implantation sleeve, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047917

12mm Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-12
Not in Commercial Distribution

  • 00846468047917 ()
83-SLEEVE-12

  • Orthopaedic implantation sleeve, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047900

10mm Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-10
Not in Commercial Distribution

  • 00846468047900 ()
83-SLEEVE-10

  • Orthopaedic implantation sleeve, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047894

8mm Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-08
Not in Commercial Distribution

  • 00846468047894 ()
83-SLEEVE-08

  • Orthopaedic implantation sleeve, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047870

16mm Rasp
Pioneer Surgical Technology, Inc.
83-RASP-16
Not in Commercial Distribution

  • 00846468047870 ()
83-RASP-16

  • Bone file/rasp, manual, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047863

14mm Rasp
Pioneer Surgical Technology, Inc.
83-RASP-14
Not in Commercial Distribution

  • 00846468047863 ()
83-RASP-14

  • Bone file/rasp, manual, reusable
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