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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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Cross-Fuse® PEEK IBF System - 00191083032443

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL18-9
Not in Commercial Distribution


  • 18mm X 9mm
35-DTRL18-9

  • Surgical implant template, reusable

Cross-Fuse® PEEK IBF System - 00191083032412

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL18-15-6
Not in Commercial Distribution


  • 18mm X 15mm, 6 Degrees
35-DTRL18-15-6

  • Surgical implant template, reusable

Cross-Fuse® PEEK IBF System - 00191083032399

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL18-13-6
Not in Commercial Distribution


  • 18mm X 13mm, 6 Degrees
35-DTRL18-13-6

  • Surgical implant template, reusable

Cross-Fuse® PEEK IBF System - 00191083032382

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL18-13
Not in Commercial Distribution


  • 18mm X 13mm
35-DTRL18-13

  • Surgical implant template, reusable

Cross-Fuse® PEEK IBF System - 00191083032368

TRIAL SPACER
Pioneer Surgical Technology, Inc.
35-DTRL18-11
Not in Commercial Distribution


  • 18mm X 11mm
35-DTRL18-11

  • Surgical implant template, reusable

obelisc™ vertebral body replacement - 04052536198818

Shaft flexible for screwdriver, hex 3.5 mm
Ulrich GmbH & Co. KG
CS 2932-3
In Commercial Distribution

CS 2932-3

  • General internal orthopaedic fixation system implantation kit

obelisc™ vertebral body replacement - 04052536198795

Locking rod flexible, length 450 mm
Ulrich GmbH & Co. KG
CS 2931-12
In Commercial Distribution

CS 2931-12

  • General internal orthopaedic fixation system implantation kit

obelisc™ vertebral body replacement - 04052536198788

Expansion rod flexible, length 450 mm
Ulrich GmbH & Co. KG
CS 2931-11
In Commercial Distribution

CS 2931-11

  • General internal orthopaedic fixation system implantation kit

obelisc™ vertebral body replacement - 04052536198771

Holder curved, length 450 mm
Ulrich GmbH & Co. KG
CS 2931-10
In Commercial Distribution

CS 2931-10

  • General internal orthopaedic fixation system implantation kit

TLC® Retractor (Wilson Penile Implantation System™) - 00842071119607

Wilson Penile Implantation System™ Retractor Frame, Retractor Stays, & Penile Elevation Strap (Boxed Tray)
APPLIED MEDICAL TECHNOLOGY, INC.
TLC5042-M
In Commercial Distribution

TLC5042-M

  • Surgical retraction system mounting frame, reusable
  • Surgical retractor/retraction system blade, single-use
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