Streamline™* MIS Spinal Fixation System 04-55-RR-240
GUDID 00846468014834
ROD, STRAIGHT
Pioneer Surgical Technology, Inc.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00846468014834 |
| NIH Device Record Key | 9f00bf67-8fc3-4dca-9f04-b3d2c2d70698 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Streamline™* MIS Spinal Fixation System |
| Version Model Number | 04-55-RR-240 |
| Catalog Number | 04-55-RR-240 |
| Company DUNS | 793384496 |
| Company Name | Pioneer Surgical Technology, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
Customer Support Contacts
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
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| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
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| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
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| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
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| Phone | +1(906)226-9909 |
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| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
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| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
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| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
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| labeling@resolvesurg.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191083019277 [Primary] |
| GS1 | 00846468014834 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| MNH | Orthosis, spondylolisthesis spinal fixation |
| NKB | Thoracolumbosacral pedicle screw system |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468014834]
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[00846468014834]
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[00846468014834]
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[00846468014834]
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Moist Heat or Steam Sterilization
[00846468014834]
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[00846468014834]
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Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-11-26 |
On-Brand Devices [Streamline™* MIS Spinal Fixation System]
| 00846468063146 | THREADED SCREW INSERTER |
| 00846468052836 | CANNULATED SCREW, POLYAXIAL |
| 00846468052829 | CANNULATED SCREW, POLYAXIAL |
| 00846468052812 | CANNULATED SCREW, POLYAXIAL |
| 00846468052805 | CANNULATED SCREW, POLYAXIAL |
| 00846468052799 | CANNULATED SCREW, POLYAXIAL |
| 00846468052690 | CANNULATED SCREW, POLYAXIAL |
| 00846468052683 | CANNULATED SCREW, POLYAXIAL |
| 00846468052676 | CANNULATED SCREW, POLYAXIAL |
| 00846468052669 | CANNULATED SCREW, POLYAXIAL |
| 00846468052652 | CANNULATED SCREW, POLYAXIAL |
| 00846468052645 | CANNULATED SCREW, POLYAXIAL |
| 00846468052553 | CANNULATED SCREW, POLYAXIAL |
| 00846468052546 | CANNULATED SCREW, POLYAXIAL |
| 00846468052539 | CANNULATED SCREW, POLYAXIAL |
| 00846468052522 | CANNULATED SCREW, POLYAXIAL |
| 00846468052515 | CANNULATED SCREW, POLYAXIAL |
| 00846468052508 | CANNULATED SCREW, POLYAXIAL |
| 00846468052492 | CANNULATED SCREW, POLYAXIAL |
| 00846468052409 | CANNULATED SCREW, POLYAXIAL |
| 00846468052393 | CANNULATED SCREW, POLYAXIAL |
| 00846468052386 | CANNULATED SCREW, POLYAXIAL |
| 00846468052379 | CANNULATED SCREW, POLYAXIAL |
| 00846468052362 | CANNULATED SCREW, POLYAXIAL |
| 00846468052355 | CANNULATED SCREW, POLYAXIAL |
| 00846468052348 | CANNULATED SCREW, POLYAXIAL |
| 00846468052324 | CANNULATED SCREW, POLYAXIAL |
| 00846468052317 | CANNULATED SCREW, POLYAXIAL |
| 00846468052300 | CANNULATED SCREW, POLYAXIAL |
| 00846468052294 | CANNULATED SCREW, POLYAXIAL |
| 00846468052287 | CANNULATED SCREW, POLYAXIAL |
| 00846468052270 | CANNULATED SCREW, POLYAXIAL |
| 00846468052263 | CANNULATED SCREW, POLYAXIAL |
| 00846468052256 | CANNULATED SCREW, POLYAXIAL |
| 00846468052249 | CANNULATED SCREW, POLYAXIAL |
| 00846468052232 | CANNULATED SCREW, POLYAXIAL |
| 00846468052225 | CANNULATED SCREW, POLYAXIAL |
| 00846468052218 | CANNULATED SCREW, POLYAXIAL |
| 00846468051983 | ROD, STRAIGHT |
| 00846468051976 | ROD, STRAIGHT |
| 00846468051969 | ROD, STRAIGHT |
| 00846468051952 | ROD, STRAIGHT |
| 00846468051945 | ROD, STRAIGHT |
| 00846468051938 | ROD, STRAIGHT |
| 00846468051921 | ROD, STRAIGHT |
| 00846468051914 | ROD, STRAIGHT |
| 00846468051907 | ROD, STRAIGHT |
| 00846468051891 | ROD, STRAIGHT |
| 00846468051884 | ROD, STRAIGHT |
| 00846468051877 | ROD, STRAIGHT |
Trademark Results [Streamline]
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