Streamline Navigated Instruments 26-DRILL-MDN

GUDID 00846468095642

OCT DRILL

Pioneer Surgical Technology, Inc.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00846468095642
• NIH Device Record Key: 2d4bf66b-5f6d-4754-93bd-44470a05709b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streamline Navigated Instruments
• Version Model Number: 26-DRILL-MDN
• Catalog Number: 26-DRILL-MDN
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468095642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200095

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

[00846468095642]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-10-14
• Device Publish Date: 2020-08-12

On-Brand Devices [Streamline Navigated Instruments]

• 00846468099503: MIS SCREW INSERTER
• 00846468099497: MIS THREADED SCREW INSERTER
• 00846468096144: TL MODULAR HANDLE
• 00846468096137: TL PEDICLE FINDER STRAIGHT FLAT TIP
• 00846468096120: TL PEDICLE FINDER STRAIGHT LENKE
• 00846468096113: TL PEDICLE FINDER STRAIGHT DUCK BILL
• 00846468096083: TL DOUBLE LEAD TAP , LONG
• 00846468096076: TL DOUBLE LEAD TAP , LONG
• 00846468096069: TL DOUBLE LEAD TAP , LONG
• 00846468096052: TL DOUBLE LEAD TAP , LONG
• 00846468096045: TL DOUBLE LEAD TAP , LONG
• 00846468096038: TL CANNULATED TAP, LONG
• 00846468096021: TL CANNULATED TAP, LONG
• 00846468096014: TL CANNULATED TAP, LONG
• 00846468096007: TL CANNULATED TAP, LONG
• 00846468095994: TL CANNULATED TAP, LONG
• 00846468095963: TL DOUBLE LEAD TAP
• 00846468095956: TL DOUBLE LEAD TAP
• 00846468095949: TL DOUBLE LEAD TAP
• 00846468095932: TL DOUBLE LEAD TAP
• 00846468095925: TL DOUBLE LEAD TAP
• 00846468095918: TL DOUBLE LEAD TAP
• 00846468095901: TL DOUBLE LEAD TAP
• 00846468095895: TL CANNULATED TAP
• 00846468095888: TL CANNULATED TAP
• 00846468095871: TL CANNULATED TAP
• 00846468095864: TL CANNULATED TAP
• 00846468095857: TL CANNULATED TAP
• 00846468095840: TL CANNULATED TAP
• 00846468095833: TL CANNULATED REDUCTION SCREW INSERTER
• 00846468095826: TL REDUCTION SCREW INSERTER
• 00846468095819: TL SCREW INSERTER, MODULAR
• 00846468095802: TL CANNULATED SCREW INSERTER
• 00846468095796: OCT FIXED TAP
• 00846468095673: OCT FIXED TAP
• 00846468095666: OCT FIXED TAP
• 00846468095659: OCT FIXED TAP
• 00846468095642: OCT DRILL
• 00846468095581: OCT STRAIGHT FINDER
• 00846468095567: MIS Pedicle Finder, Cannulated, Straight
• 00846468095550: MIS CANNULATED TAP, THREADED TIP, LONG
• 00846468095543: MIS CANNULATED TAP, THREADED TIP, LONG
• 00846468095536: MIS CANNULATED TAP, THREADED TIP, LONG
• 00846468095529: MIS CANNULATED TAP, THREADED TIP, LONG
• 00846468095512: MIS CANNULATED TAP , LONG
• 00846468095505: MIS CANNULATED TAP , LONG
• 00846468095499: MIS CANNULATED TAP , LONG
• 00846468095482: MIS CANNULATED TAP , LONG
• 00846468095475: MIS CANNULATED TAP , LONG
• 00846468095468: MIS CANNULATED TAP, THREADED TIP