110088

GUDID 23596010033783

BONE SPIKES

Smith & Nephew, Inc.

Bone awl, reusable

• Primary Device ID: 23596010033783
• NIH Device Record Key: a79b005f-8da4-4d64-8452-c18b80c3a23e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 110088
• Catalog Number: 110088
• 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
• 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	03596010033789 [Primary]
GS1	23596010033783 [Package]; Contains: 03596010033789; Package: BX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121393

FDA Product Code

• HRY: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

[23596010033783]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-06-10
• Device Publish Date: 2015-08-29

Devices Manufactured by Smith & Nephew, Inc.

• 00885556905463 - NA: 2024-12-25 INSERT TRIAL PITCHFORK
• 00885556915288 - NA: 2024-12-25 LM/RL TIBIA ALIGNMENT GUIDE SHORT
• 00885556921517 - Trigen: 2024-12-10 Swivel Guide Bolt Wrench
• 00885556921388 - Legion: 2024-12-04 Legion AP Cutting Block - Size 8
• 00885556921395 - Legion: 2024-12-04 Legion AP Cutting Block - Size 7
• 00885556921401 - Legion: 2024-12-04 Legion AP Cutting Block - Size 6
• 00885556921418 - Legion: 2024-12-04 Legion AP Cutting Block - Size 5
• 00885556921449 - Trigen: 2024-12-04 12.5mm Rigid Entry Reamer