Streamline

GUDID 00810076560014

NAV MIS CANNULATED SIMPLE SCRE INSERTER SHAFT

Surgalign Spine Technologies, Inc.

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable

• Primary Device ID: 00810076560014
• NIH Device Record Key: 9b1c5dfb-aaa2-4478-8566-ef5e2f255e94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streamline
• Version Model Number: 05-SCREWINS-CL-MDN
• Company DUNS: 014520584
• Company Name: Surgalign Spine Technologies, 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: false
• 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: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810076560014 [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

[00810076560014]

Moist Heat or Steam Sterilization

[00810076560014]

Moist Heat or Steam Sterilization

[00810076560014]

Moist Heat or Steam Sterilization

[00810076560014]

Moist Heat or Steam Sterilization

[00810076560014]

Moist Heat or Steam Sterilization

[00810076560014]

Moist Heat or Steam Sterilization

[00810076560014]

Moist Heat or Steam Sterilization

[00810076560014]

Moist Heat or Steam Sterilization

[00810076560014]

Moist Heat or Steam Sterilization

[00810076560014]

Moist Heat or Steam Sterilization

[00810076560014]

Moist Heat or Steam Sterilization

[00810076560014]

Moist Heat or Steam Sterilization

[00810076560014]

Moist Heat or Steam Sterilization

[00810076560014]

Moist Heat or Steam Sterilization

[00810076560014]

Moist Heat or Steam Sterilization

[00810076560014]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-22
• Device Publish Date: 2021-11-12

On-Brand Devices [Streamline]

• 00810076560090: NAV MIS CANNULATED TAP 7.5mm (D)
• 00810076560373: NAV TL DOUBLE LEAD TAP 8.5MM (D)
• 00810076560366: NAV TL DOUBLE LEAD TAP 7.5MM (D)
• 00810076560359: NAV TL DOUBLE LEAD TAP 6.5MM (D)
• 00810076560342: NAV TL DOUBLE LEAD TAP 5.5MM (D)
• 00810076560335: NAV TL DOUBLE LEAD TAP 4.5MM (D)
• 00810076560328: NAV TL PEDICLE FINDER STRAIGHT FLAT TIP
• 00810076560311: NAV TL PEDICLE FINDER STRAIGHT LENKE
• 00810076560304: NAV TL PEDICLE FINDER STRAIGHT DUCK BILL
• 00810076560298: NAV TL SCREW INSERTER SHAFT, SOLID
• 00810076560120: NAV MIS CANNULATED TAP 9.5mm (D)
• 00810076560113: NAV MIS CANNULATED TAP 8.5mm (D)
• 00810076560106: 1/4" SQUARE QUICK CONNECT HANDLE
• 00810076560083: NAV MIS CANNULATED TAP 6.5mm (D)
• 00810076560076: NAV MIS CANNULATED TAP 5.5mm (D)
• 00810076560069: NAV MIS CANNULATED TAP 4.5mm (D)
• 00810076560052: NAV MIS CANNULATED TAP 4.0mm (D)
• 00810076560045: NAV MIS PEDICLE FINDER, CANN, STRAIGHT
• 00810076560038: NAV MIS CANN DRILL 3.8mm (D) X 55mm (L)
• 00810076560014: NAV MIS CANNULATED SIMPLE SCRE INSERTER SHAFT