Streamline

GUDID 00810076560113

NAV MIS CANNULATED TAP 8.5mm (D)

Surgalign Spine Technologies, Inc.

Surgical screwdriver, reusable

• Primary Device ID: 00810076560113
• NIH Device Record Key: c37492d1-156f-45b1-9fd2-72a5836bc528
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streamline
• Version Model Number: 04-CANNTAP-85-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	00810076560113 [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

[00810076560113]

Moist Heat or Steam Sterilization

[00810076560113]

Moist Heat or Steam Sterilization

[00810076560113]

Moist Heat or Steam Sterilization

[00810076560113]

Moist Heat or Steam Sterilization

[00810076560113]

Moist Heat or Steam Sterilization

[00810076560113]

Moist Heat or Steam Sterilization

[00810076560113]

Moist Heat or Steam Sterilization

[00810076560113]

Moist Heat or Steam Sterilization

[00810076560113]

Moist Heat or Steam Sterilization

[00810076560113]

Moist Heat or Steam Sterilization

[00810076560113]

Moist Heat or Steam Sterilization

[00810076560113]

Moist Heat or Steam Sterilization

[00810076560113]

Moist Heat or Steam Sterilization

[00810076560113]

Moist Heat or Steam Sterilization

[00810076560113]

Moist Heat or Steam Sterilization

[00810076560113]

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