| Primary Device ID | 00191083003894 |
| NIH Device Record Key | a5ab9be5-b6a5-46fa-b894-b01c30b42917 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EVOS Cabling System |
| Version Model Number | 56-71175684 |
| Catalog Number | 71175684 |
| 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 | true |
| 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 |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
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| Phone | +1(906)226-9909 |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191083003894 [Primary] |
| HXI | PASSER, WIRE, ORTHOPEDIC |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
[00191083003894]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-09 |
| Device Publish Date | 2021-02-01 |
| 00191083004013 | Cable Instrument Tray Lid |
| 00191083004006 | Cable Instrument Tray |
| 00191083003993 | Cable Crimper |
| 00191083003986 | Cable Tensioner Nose Cone |
| 00191083003979 | Cable Stainless Steel w/Crimp |
| 00191083003962 | Scissor Cutter |
| 00191083003955 | Cable Flush Cutter |
| 00191083003948 | Provisional Cable Tensioner |
| 00191083003931 | Cable Tensioner |
| 00191083003924 | Angled Cable Passer, 60mm |
| 00191083003917 | Angled Cable Passer, 50mm |
| 00191083003900 | Angled Cable Passer, 40mm |
| 00191083003894 | Straight Cable Passer, 60mm |
| 00191083003887 | Straight Cable Passer, 50mm |
| 00191083003870 | Straight Cable Passer, 40mm |
| 00191083003863 | Curved Cable Passer, 60mm |
| 00191083003856 | Curved Cable Passer, 50mm |
| 00191083003849 | Curved Cable Passer, 40mm |