210261

GUDID 03596010102270

PIN CUTTER 3.9MM CAPACITY

Smith & Nephew, Inc.

Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter Orthopaedic implantable-device cutter

• Primary Device ID: 03596010102270
• NIH Device Record Key: 99426276-be94-44c9-8abe-b89b1143ab0c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 210261
• Catalog Number: 210261
• Company DUNS: 045483575
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010102270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093047

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[03596010102270]

Moist Heat or Steam Sterilization

[03596010102270]

Moist Heat or Steam Sterilization

[03596010102270]

Moist Heat or Steam Sterilization

[03596010102270]

Moist Heat or Steam Sterilization

[03596010102270]

Moist Heat or Steam Sterilization

[03596010102270]

Moist Heat or Steam Sterilization

[03596010102270]

Moist Heat or Steam Sterilization

[03596010102270]

Moist Heat or Steam Sterilization

[03596010102270]

Moist Heat or Steam Sterilization

[03596010102270]

Moist Heat or Steam Sterilization

[03596010102270]

Moist Heat or Steam Sterilization

[03596010102270]

Moist Heat or Steam Sterilization

[03596010102270]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-07
• Device Publish Date: 2015-08-25

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• 00885556902721 - INTELLIO SHIFT: 2024-05-21 NEO CONTROLLER SERVICE
• 00885556918562 - R3: 2024-05-21 R3 CONSTRAINED LINER 48MM
• 00885556918579 - TRIGEN: 2024-05-21 SHORT METATAN 10MM X 20CM LEFT
• 00885556918593 - TRIGEN: 2024-05-21 SHORT METATAN 10MM X 20CM LEFT
• 00885556918609 - TRIGEN: 2024-05-21 SHORT METATAN 10MM X 20CM RIGHT
• 00885556805015 - INTELLIO SHIFT: 2024-05-17 INTELLIO SHIFT Wired Foot Pedal