| Primary Device ID | 00846468001292 |
| NIH Device Record Key | d0de9a04-b943-46a5-8661-c60dd9a533df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Streamline TL Spinal Fixation System |
| Version Model Number | 10-55-RR-100 |
| Catalog Number | 10-55-RR-100 |
| 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 |
| Phone | +1(386)418-8888 |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191083024875 [Primary] |
| GS1 | 00846468001292 [Primary] |
| GS1 | 00846468019396 [Previous] |
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| KWQ | Appliance, fixation, spinal intervertebral body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
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[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
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[00846468001292]
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[00846468001292]
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[00846468001292]
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[00846468001292]
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[00846468001292]
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[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
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[00846468001292]
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[00846468001292]
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[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
[00846468001292]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-13 |
| Device Publish Date | 2021-05-05 |
| 00846468080839 | Instrument Case, Empty |
| 00846468080822 | Instrument Case, Empty |
| 00846468080815 | Instrument Case, Empty |
| 00846468080808 | Instrument Case, Empty |
| 00846468080792 | Caddy, Crosslink, Variable, Empty |
| 00846468080785 | Case, Crosslink, Empty |
| 00846468080778 | Long Rod Caddy, Empty |
| 00846468080761 | Long Rod Caddy, Empty |
| 00846468080754 | Caddy, Crosslink, Fixed, Empty |
| 00846468080747 | Lateral Offset Caddy, Empty |
| 00846468080730 | Caddy, Rod Connector, Empty |
| 00846468080723 | Implant Case, Empty |
| 00846468080716 | Medium Rod Caddy, Empty |
| 00846468080709 | Small Rod Caddy, Empty |
| 00846468080693 | Large Rod Caddy, Empty |
| 00846468080686 | 9.5mm Screw Caddy, Long, Polyaxial, Empty |
| 00846468080679 | 9.5mm Screw Caddy, Polyaxial, Empty |
| 00846468080662 | 8.5mm Screw Caddy, Long, Polyaxial, Empty |
| 00846468080655 | 8.5mm Screw Caddy, Polyaxial, Empty |
| 00846468080648 | 7.5mm Screw Caddy, Long, Polyaxial, Empty |
| 00846468080631 | 6.5mm Screw Caddy, Long, Polyaxial, Empty |
| 00846468080624 | 4.5mm Screw Caddy, Polyaxial, Empty |
| 00846468080617 | Screw Caddy, Cannulated, Polyaxial, Reduction |
| 00846468080600 | Screw Caddy, Cannulated, Polyaxial, Reduction |
| 00846468080594 | Screw Caddy, Cannulated, Polyaxial, Reduction |
| 00846468080587 | 7.5mm Screw Caddy, Fixed, Empty |
| 00846468080570 | 6.5mm Screw Caddy, Fixed, Empty |
| 00846468080563 | 5.5mm Screw Caddy, Fixed, Empty |
| 00846468080556 | 4.5mm Screw Caddy, Fixed, Empty |
| 00846468080549 | 7.5mm Screw Caddy, Polyaxial, Empty |
| 00846468080532 | 6.5mm Screw Caddy, Polyaxial, Empty |
| 00846468080525 | 5.5mm Screw Caddy, Polyaxial, Empty |
| 00846468080518 | Implant Case, Empty |
| 00846468079734 | CROSSLINK HOLDER |
| 00846468006907 | Set Screw Caddy, Empty |
| 00846468006631 | CROSSLINK COUNTER TORQUE TUBE |
| 00846468006624 | VARIABLE CROSSLINK BENDER MALE |
| 00846468006617 | VARIABLE CROSSLINK BENDER FEMALE |
| 00846468006600 | FIXED CROSSLINK BENDER RIGHT |
| 00846468006594 | FIXED CROSSLINK BENDER LEFT |
| 00846468006549 | CADDY, X-LINK, FIXED |
| 00846468006402 | CROSSLINK TORQUE HANDLE |
| 00846468006396 | CROSSLINK PROVISIONAL INSERTER |
| 00846468006389 | CROSSLINK GAUGE |
| 00846468006372 | CROSSLINK FINAL DRIVER |
| 00846468001834 | STREAMLINE TL, BANDED PEDICLE MARKER |
| 00846468000530 | STREAMLINE TL, REDUCTION SCREW DEROTATOR |
| 00846468000103 | STREAMLINE TL, DISTRACTOR, STRAIGHT TIP |
| 00846468000097 | STREAMLINE TL, COMPRESSOR, STRAIGHT TIP |
| 00846468032951 | STREAMLINE TL, ROD WRENCH,ORIENTATED HEX |