C-Plus PEEK IBF System 725-175

GUDID 00846468005146

UNI-CORTICAL 14X16X9mm TRIAL

Pioneer Surgical Technology, Inc.

Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: 00846468005146
• NIH Device Record Key: f91c3cdf-0dd9-46b1-837d-2b7731545df0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-Plus PEEK IBF System
• Version Model Number: 725-175
• Catalog Number: 725-175
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com
• Phone: +1(386)418-8888
• Email: labelrequest@resolvesurg.com

Device Dimensions

• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468005146 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00846468005146]

Moist Heat or Steam Sterilization

[00846468005146]

Moist Heat or Steam Sterilization

[00846468005146]

Moist Heat or Steam Sterilization

[00846468005146]

Moist Heat or Steam Sterilization

[00846468005146]

Moist Heat or Steam Sterilization

[00846468005146]

Moist Heat or Steam Sterilization

[00846468005146]

Moist Heat or Steam Sterilization

[00846468005146]

Moist Heat or Steam Sterilization

[00846468005146]

Moist Heat or Steam Sterilization

[00846468005146]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-27
• Device Publish Date: 2022-07-19

On-Brand Devices [C-Plus PEEK IBF System]

• 00846468057213: MODULAR HANDLE
• 00846468031794: TRIAL SPACER
• 00846468031787: TRIAL SPACER
• 00846468031770: TRIAL SPACER
• 00846468031763: TRIAL SPACER
• 00846468031756: TRIAL SPACER
• 00846468031749: TRIAL SPACER
• 00846468031732: TRIAL SPACER
• 00846468031725: TRIAL SPACER
• 00846468031718: TRIAL SPACER
• 00846468031701: TRIAL SPACER
• 00846468031695: TRIAL SPACER
• 00846468031688: TRIAL SPACER
• 00846468031671: TRIAL SPACER
• 00846468031664: TRIAL SPACER
• 00846468031657: TRIAL SPACER
• 00846468031640: TRIAL SPACER
• 00846468031633: TRIAL SPACER
• 00846468031626: TRIAL SPACER
• 00846468031619: TRIAL SPACER
• 00846468031602: TRIAL SPACER
• 00846468031596: TRIAL SPACER
• 00846468031541: RING CURETTE
• 00846468031534: RASP
• 00846468031510: INSERTER WITH STOP
• 00846468031503: INSERTER
• 00846468031497: INSTRUMENT CASE
• 00191083026886: C-PLUS, 14.5x17 NO STOP TRIAL RASP, 11mm
• 00191083026879: C-PLUS, 14.5x17 NO STOP TRIAL RASP, 10mm
• 00191083026862: C-PLUS, 14.5x17 NO STOP TRIAL RASP, 9mm
• 00191083026855: C-PLUS, 14.5x17 NO STOP TRIAL RASP, 8mm
• 00191083026848: C-PLUS, 14.5x17 NO STOP TRIAL RASP, 7mm
• 00191083026831: C-PLUS, 14.5x17 NO STOP TRIAL RASP, 6mm
• 00191083026824: C-PLUS, 14.5x17 NO STOP TRIAL RASP, 5mm
• 00191083026817: C-PLUS, 14.5x17 TRIAL RASP, 11mm
• 00191083026800: C-PLUS, 14.5x17 TRIAL RASP, 10mm
• 00191083026794: C-PLUS, 14.5x17 TRIAL RASP, 9mm
• 00191083026787: C-PLUS, 14.5x17 TRIAL RASP, 8mm
• 00191083026770: C-PLUS, 14.5x17 TRIAL RASP, 7mm
• 00191083026763: C-PLUS, 14.5x17 TRIAL RASP, 6mm
• 00191083026756: C-PLUS, 14.5x17 TRIAL RASP, 5mm
• 00191083026749: C-PLUS, 12x14 NO STOP TRIAL RASP, 11mm
• 00191083026732: C-PLUS, 12x14 NO STOP TRIAL RASP, 10mm
• 00191083026725: C-PLUS, 12x14 NO STOP TRIAL RASP, 9mm
• 00191083026718: C-PLUS, 12x14 NO STOP TRIAL RASP, 8mm
• 00191083026701: C-PLUS, 12x14 NO STOP TRIAL RASP, 7mm
• 00191083026695: C-PLUS, 12x14 NO STOP TRIAL RASP, 6mm
• 00191083026688: C-PLUS, 12x14 NO STOP TRIAL RASP, 5mm
• 00191083026671: C-PLUS, 12x14 TRIAL RASP, 11mm
• 00191083026664: C-PLUS, 12x14 TRIAL RASP, 10mm