| Primary Device ID | 00846468005153 |
| NIH Device Record Key | 5e202560-15d1-47c2-99aa-cd6f7ad74f92 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | C-Plus PEEK IBF System |
| Version Model Number | 725-176 |
| Catalog Number | 725-176 |
| 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 |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Height | 10 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846468005153 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
[00846468005153]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-27 |
| Device Publish Date | 2022-07-19 |
| 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 |