Streamline OCT Occipito-Cervico-Thoracic System 26-OCPS-525-9

GUDID 00846468048372

OCCIPITAL SCREW

Pioneer Surgical Technology, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00846468048372
• NIH Device Record Key: 5d39414c-f1d3-4a35-a6d9-fd4ebf08b4a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streamline OCT Occipito-Cervico-Thoracic System
• Version Model Number: 26-OCPS-525-9
• Catalog Number: 26-OCPS-525-9
• 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
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468048372 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150254

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

[00846468048372]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-05
• Device Publish Date: 2020-09-25

On-Brand Devices [Streamline OCT Occipito-Cervico-Thoracic System]

• 00846468000011: STREAMLINE OCT, RIGID SCREW INSERTER
• 00846468093211: ROD, PRE-BENT
• 00846468093204: ROD, PRE-BENT
• 00846468093198: ROD, PRE-BENT
• 00846468093181: ROD, PRE-BENT
• 00846468093174: ROD, PRE-BENT
• 00846468093167: ROD, PRE-BENT
• 00846468093150: ROD, PRE-BENT
• 00846468093143: ROD, PRE-BENT
• 00846468093136: ROD, PRE-BENT
• 00846468095635: Pre-Bent Rod Case, Empty
• 00846468058227: SCREW, HIGH ANGLE
• 00846468058203: SCREW, HIGH ANGLE
• 00846468058197: SCREW, HIGH ANGLE
• 00846468058173: SCREW, HIGH ANGLE
• 00846468058166: SCREW, HIGH ANGLE
• 00846468058142: SCREW, HIGH ANGLE
• 00846468058135: SCREW, HIGH ANGLE
• 00846468057800: SCREW, HIGH ANGLE
• 00846468057787: SCREW, HIGH ANGLE
• 00846468057770: SCREW, HIGH ANGLE
• 00846468057756: SCREW, HIGH ANGLE
• 00846468057749: SCREW, HIGH ANGLE
• 00846468057725: SCREW, HIGH ANGLE
• 00846468057718: SCREW, HIGH ANGLE
• 00846468057282: HEAD-TO-HEAD CROSSLINK - XXL
• 00846468057275: HEAD-TO-HEAD CROSSLINK - XL
• 00846468054656: ROD-TO-ROD CROSSLINK, EXTRA-EXTRA-LARGE
• 00846468054649: ROD-TO-ROD CROSSLINK, EXTRA-LARGE
• 00846468048501: OCCIPITAL SCREW, SPLIT-TIP
• 00846468048488: OCCIPITAL SCREW, SPLIT-TIP
• 00846468048464: OCCIPITAL SCREW, SPLIT-TIP
• 00846468048433: OCCIPITAL SCREW, SPLIT-TIP
• 00846468048419: OCCIPITAL SCREW, SPLIT-TIP
• 00846468048396: OCCIPITAL SCREW, SPLIT-TIP
• 00846468048372: OCCIPITAL SCREW
• 00846468048358: OCCIPITAL SCREW
• 00846468048327: OCCIPITAL SCREW
• 00846468048303: OCCIPITAL SCREW
• 00846468048280: OCCIPITAL SCREW
• 00846468048266: OCCIPITAL SCREW
• 00846468048242: OCCIPITAL SCREW
• 00846468048211: OCCIPITAL SCREW
• 00846468048198: OCCIPITAL SCREW
• 00846468048174: OCCIPITAL SCREW
• 00846468000349: Pre-Bent Rod Case
• 00846468000332: Option Case 2
• 00846468000325: Option Case
• 00846468000318: Occipital Case 2
• 00846468000301: Occipital Case