110338

GUDID 03596010469601

HIBBS OSTEOTOME CVD 28.5MM

Smith & Nephew, Inc.

Orthopaedic osteotome

• Primary Device ID: 03596010469601
• NIH Device Record Key: 680f689c-eb01-4315-8780-9044c5ce1e47
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 110338
• Catalog Number: 110338
• 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	03596010469601 [Primary]

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

[03596010469601]

Moist Heat or Steam Sterilization

[03596010469601]

Moist Heat or Steam Sterilization

[03596010469601]

Moist Heat or Steam Sterilization

[03596010469601]

Moist Heat or Steam Sterilization

[03596010469601]

Moist Heat or Steam Sterilization

[03596010469601]

Moist Heat or Steam Sterilization

[03596010469601]

Moist Heat or Steam Sterilization

[03596010469601]

Moist Heat or Steam Sterilization

[03596010469601]

Moist Heat or Steam Sterilization

[03596010469601]

Moist Heat or Steam Sterilization

[03596010469601]

Moist Heat or Steam Sterilization

[03596010469601]

Moist Heat or Steam Sterilization

[03596010469601]

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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• 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