TRIGEN 71631410

GUDID 00885556158432

META-TAN ALIGNMENT ARM

Smith & Nephew, Inc.

Orthopaedic stereotactic surgery system

• Primary Device ID: 00885556158432
• NIH Device Record Key: b2709115-9bb1-46d3-a71e-d780c0477aa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIGEN
• Version Model Number: 71631410
• Catalog Number: 71631410
• Company DUNS: 109903521
• Company Name: Smith & Nephew, 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: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556158432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123055

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[00885556158432]

Moist Heat or Steam Sterilization

[00885556158432]

Moist Heat or Steam Sterilization

[00885556158432]

Moist Heat or Steam Sterilization

[00885556158432]

Moist Heat or Steam Sterilization

[00885556158432]

Moist Heat or Steam Sterilization

[00885556158432]

Moist Heat or Steam Sterilization

[00885556158432]

Moist Heat or Steam Sterilization

[00885556158432]

Moist Heat or Steam Sterilization

[00885556158432]

Moist Heat or Steam Sterilization

[00885556158432]

Moist Heat or Steam Sterilization

[00885556158432]

Moist Heat or Steam Sterilization

[00885556158432]

Moist Heat or Steam Sterilization

[00885556158432]

Moist Heat or Steam Sterilization

[00885556158432]

Moist Heat or Steam Sterilization

[00885556158432]

Moist Heat or Steam Sterilization

[00885556158432]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-28

On-Brand Devices [TRIGEN]

• 00885556741610: 12.5MM ENTRY REAMER
• 00885556740729: K-WIRE DEPTH GAUGE
• 00885556740712: WIRE W/LOOP END
• 00885556740682: 11.5MM DEEP FLUTED END CUTTING REAMER
• 00885556740675: 11MM END CUTTING REAMER HEAD
• 00885556740545: EXTENDED TRIGEN OBTURATOR
• 00885556739945: DEPTH GAUGE
• 00885556739846: 800MM BULLET NOSE RULER
• 00885556739662: 800MM BULLET NOSE RULER
• 00885556739655: 800MM BULLET NOSE RULER
• 00885556739204: 11.5MM REAMER HEAD
• 00885556739174: 15.5MM REAMER HEAD
• 00885556739167: 12.5MM REAMER HEAD
• 00885556738139: 11.5MM END CUTTING REAMER
• 00885556738122: 11.5MM DEEP FLUTED END CUTTING REAMER
• 00885556738115: 11MM END CUTTING REAMER
• 00885556738108: 11MM DEEP FLUTED END CUTTING REAMER
• 00885556736593: SS FEMORAL ANTEGRADE KNEE FUSION NAIL 10MM X 65CM RIGHT
• 00885556736586: SS FEMORAL ANTEGRADE KNEE FUSION NAIL 10MM X 70CM RIGHT
• 00885556736579: SS FEMORAL ANTEGRADE KNEE FUSION NAIL 10MM X 65CM RIGHT
• 00885556736562: SS FEMORAL ANTEGRADE KNEE FUSION NAIL 10MM X 75CM LEFT
• 00885556736555: SS FEMORAL ANTEGRADE KNEE FUSION NAIL 10MM X 65CM LEFT
• 00885556735992: EXTENDED TRIGEN OBTURATOR
• 00885556735978: TRIGEN DEPTH GAGE
• 00885556734308: 800MM BULLET NOSE RULER
• 00885556734292: SEMI-EXTENDED TROCAR
• 00885556734285: SEMI-EXTENDED ENTRY TUBE
• 00885556734209: RETROGRADE META NAIL GUIDE BOLT
• 00885556734193: RETROGRADE META NAIL GUIDE BARREL
• 00885556734186: RETROGRADE META NAIL GUIDE DROP
• 00885556734148: 11MM END CUTTING REAMER HEAD
• 00885556732489: TRIGEN HINDFOOT FUSION NAIL 13MM X 20CM LEFT
• 00885556732427: 11MM END CUTTING REAMER HEAD
• 00885556732311: INTERTAN GOLD GUIDE PIN SLEEVE - SHORT
• 00885556732304: INTERTAN GOLD DRILL GUIDE - SHORT
• 00885556732298: INTERTAN GUIDE PIN SLEEVE - SHORT
• 00885556732281: INTERTAN DRILL SLEEVE - SHORT
• 00885556728079: RETROGRADE META NAIL GUIDE BOLT
• 00885556728062: RETROGRADE META NAIL GUIDE BARREL
• 00885556728055: RETROGRADE META NAIL GUIDE DROP
• 00885556727676: TRIGEN HINDFOOT FUSION NAIL 13MM X 20CM RIGHT
• 00885556726686: SMOOTH BARREL STANDARD DRILL GUIDE
• 00885556725146: ONE PIECE FLEXIBLE REAMER - 13MM
• 00885556725139: ONE PIECE FLEXIBLE REAMER - 11.5MM
• 00885556725115: 11.5MM REAMER HEAD
• 00885556725108: 11MM REAMER HEAD
• 00885556725092: 11.5MM REAMER HEAD
• 00885556725085: 11MM REAMER HEAD
• 00885556725078: 11.5MM REAMER HEAD
• 00885556725061: LAG SCREW DRIVER W/ HALL-JACOBS ADAPTER