Primary Device ID | 00846468066437 |
NIH Device Record Key | 59f1cfa6-a4fc-4f7e-80de-9f1ec23f24dc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Streamline® OCT Occipito-Cervico-Thoracic System |
Version Model Number | 26-PA-SS-40-42 |
Catalog Number | 26-PA-SS-40-42 |
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(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00846468066437 [Primary] |
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
[00846468066437]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-11-06 |
Device Publish Date | 2018-10-06 |
00846468084974 | Head to Head Crosslink Bender |
00846468084394 | Drill, Stubby |
00846468084387 | Drill, Flex |
00846468084370 | Drill, Standard |
00846468084363 | Torque Limiting Handle, 23 in-lbs |
00846468084356 | DISTRACTOR, PARALLEL |
00846468084349 | COMPRESSOR, PARALLEL |
00846468083847 | YOKE MANIPULATOR |
00846468083830 | Counter Torque Tube, Connector |
00846468083823 | Counter Torque Tube, Inline |
00846468083786 | LOCKING SCREW INSERTER |
00846468083779 | ROD REDUCER |
00846468083762 | Rocker Reducer |
00846468083755 | Occipital-Cervical Assembly |
00846468083748 | Occipital-Cervical Assembly |
00846468083731 | Occipital-Cervical Assembly |
00846468083724 | Occipital-Cervical Assembly |
00846468083717 | ROD-TO-ROD CONNECTOR, 3.2mm-5.5mm CLOSED, 2X1 |
00846468083700 | ROD-TO-ROD CONNECTOR, 3.2mm-5.5mm, INLINE, 1X1 |
00846468083694 | ROD-TO-ROD CONNECTOR, 3.2mm-5.5mm, OPEN, 1X1 |
00846468083687 | ROD-TO-ROD CONNECTOR, 3.2mm-5.5mm, CLOSED, 1X1 |
00846468083670 | ROD-TO-ROD CONNECTOR, 3.2mm-3.2mm, CLOSED, 1X1 |
00846468083625 | Pedicle Screw, Polyaxial, 4.0mm x 34mm |
00846468083618 | Pedicle Screw, Polyaxial, 4.0mm x 32mm |
00846468083564 | Pedicle Screw, Polyaxial, 3.5mm x 34mm |
00846468083557 | Pedicle Screw, Polyaxial, 3.5mm x 32mm |
00846468080914 | ROD TEMPLATE |
00846468080907 | ROD TEMPLATE |
00846468079949 | PEDICLE SCREW, POLYAXIAL |
00846468079932 | PEDICLE SCREW, POLYAXIAL |
00846468079925 | PEDICLE SCREW, POLYAXIAL |
00846468079918 | PEDICLE SCREW, POLYAXIAL |
00846468079901 | PEDICLE SCREW, POLYAXIAL |
00846468079895 | PEDICLE SCREW, POLYAXIAL |
00846468079888 | PEDICLE SCREW, POLYAXIAL |
00846468079871 | PEDICLE SCREW, POLYAXIAL |
00846468079864 | PEDICLE SCREW, POLYAXIAL |
00846468079857 | PEDICLE SCREW, POLYAXIAL |
00846468079840 | PEDICLE SCREW, POLYAXIAL |
00846468079833 | PEDICLE SCREW, POLYAXIAL |
00846468079826 | PEDICLE SCREW, POLYAXIAL |
00846468079819 | PEDICLE SCREW, POLYAXIAL |
00846468079802 | PEDICLE SCREW, POLYAXIAL |
00846468079796 | PEDICLE SCREW, POLYAXIAL |
00846468079727 | 3.2mm To 5.5mm Transition Rod |
00846468079710 | 3.2mm To 5.5mm Transition Rod |
00846468079697 | FINAL LOCKER |
00846468078065 | FINAL DRIVER |
00846468078041 | Pre-Bent Co-Cr Rod, 110mm length |
00846468078034 | Pre-Bent Co-Cr Rod, 90mm length |