General Instrument SR-0249

GUDID 10889981158033

Head Inserter w/ Long Shaft

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10889981158033
• NIH Device Record Key: 59f78e79-6f08-4a2f-b9ac-b2d66c3fe192
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: General Instrument
• Version Model Number: SR-0249
• Catalog Number: SR-0249
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• 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: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981158033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160902

FDA Product Code

• MNI: Orthosis, spinal pedicle fixation

Sterilization

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

[10889981158033]

Moist Heat or Steam Sterilization

[10889981158033]

Moist Heat or Steam Sterilization

[10889981158033]

Moist Heat or Steam Sterilization

[10889981158033]

Moist Heat or Steam Sterilization

[10889981158033]

Moist Heat or Steam Sterilization

[10889981158033]

Moist Heat or Steam Sterilization

[10889981158033]

Moist Heat or Steam Sterilization

[10889981158033]

Moist Heat or Steam Sterilization

[10889981158033]

Moist Heat or Steam Sterilization

[10889981158033]

Moist Heat or Steam Sterilization

[10889981158033]

Moist Heat or Steam Sterilization

[10889981158033]

Moist Heat or Steam Sterilization

[10889981158033]

Moist Heat or Steam Sterilization

[10889981158033]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-02
• Device Publish Date: 2020-09-24

On-Brand Devices [General Instrument]

• 10889987164526: Shortened Small Stature Counter Torque
• 10889987163321: 1/4" Multi-Angle-Osteotome
• 10889987163284: 7.5mm Lenke Probe
• 10889981160296: HEAD ADJUSTER
• 10889981159375: Head Turner w/ T Bar
• 10889981158033: Head Inserter w/ Long Shaft
• 10889981157814: 4mm Paddle Spreader
• 10889981157616: A/O Driver w/ Translating Sleeve
• 10889981157579: Prime NM 39X30mm All-In-One Trial 16mm 15Deg
• 10889981157562: Prime NM 39X30mm All-In-One Trial 14mm 15Deg
• 10889981157555: Prime NM 39X30mm All-In-One Trial 12mm 15Deg
• 10889981157548: Prime NM 39X30mm All-In-One Trial 16mm 10Deg
• 10889981157531: Prime NM 39X30mm All-In-One Trial 14mm 10Deg
• 10889981157524: Prime NM 39X30mm All-In-One Trial 12mm 10Deg
• 10889981157517: Prime NM 39X30mm All-In-One Trial 10mm 10Deg
• 10889981157500: Prime NM 35X27mm All-In-One Trial 16mm 15Deg
• 10889981157494: Prime NM 35X27mm All-In-One Trial 14mm 15Deg
• 10889981157487: Prime NM 35X27mm All-In-One Trial 12mm 15Deg
• 10889981157470: Prime NM 35X27mm All-In-One Trial 16mm 10Deg
• 10889981157463: Prime NM 35X27mm All-In-One Trial 14mm 10Deg
• 10889981157456: Prime NM 35X27mm All-In-One Trial 12mm 10Deg
• 10889981157449: Prime NM 35X27mm All-In-One Trial 10mm 10Deg
• 10889981157432: Prime NM 31X24mm All-In-One Trial 16mm 15Deg
• 10889981157425: Prime NM 31X24mm All-In-One Trial 14mm 15Deg
• 10889981157418: Prime NM 31X24mm All-In-One Trial 12mm 15Deg
• 10889981157401: Prime NM 31X24mm All-In-One Trial 16mm 10Deg
• 10889981157395: Prime NM 31X24mm All-In-One Trial 14mm 10Deg
• 10889981157388: Prime NM 31X24mm All-In-One Trial 12mm 10Deg
• 10889981157371: Prime NM 31X24mm All-In-One Trial 10mm 10Deg
• 10889981156367: Screw Shank Driver
• 10889981156336: Short Final Driver
• 10889981156329: Short Counter Torque
• 10889981155933: Modular Split Tip T30
• 10889981154660: Driver w/ Handle Stop
• 10889981154127: Inline Cupped Compressor
• 10889981153939: Cannulated Circular Reamer
• 10889981153922: Tap, Dia 7.50mm
• 10889981153915: Tap, Dia 6.50mm
• 10889981153908: Tap, Dia 5.50mm
• 10889981153892: Tap, Dia 4.50mm
• 10889981153885: Driver w/ Handle Stop
• 10889981153748: Dilator 5, Threaded
• 10889981153731: Dilator 4, Threaded
• 10889981153724: Dilator 3, Threaded
• 10889981153717: Dilator 2, Threaded
• 10889981153700: Dilator 1, Threaded
• 10889981149598: Tubular Rod Bender
• 10889981149581: SP Compressor, 285mm
• 10889981149468: T15 Driver, Short
• 10889981164522: Shortened Small Stature Counter Torque