C5954

GUDID 03596010581716

IMPACTOR CAP

Smith & Nephew, Inc.

Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable

• Primary Device ID: 03596010581716
• NIH Device Record Key: 0a996ae9-b198-4129-88b6-40b2952b5d70
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: C5954
• Catalog Number: C5954
• 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	03596010581716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040033

FDA Product Code

• NXT: Prosthesis, hip, semi-constrained, metal/metal, resurfacing

Sterilization

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

[03596010581716]

Moist Heat or Steam Sterilization

[03596010581716]

Moist Heat or Steam Sterilization

[03596010581716]

Moist Heat or Steam Sterilization

[03596010581716]

Moist Heat or Steam Sterilization

[03596010581716]

Moist Heat or Steam Sterilization

[03596010581716]

Moist Heat or Steam Sterilization

[03596010581716]

Moist Heat or Steam Sterilization

[03596010581716]

Moist Heat or Steam Sterilization

[03596010581716]

Moist Heat or Steam Sterilization

[03596010581716]

Moist Heat or Steam Sterilization

[03596010581716]

Moist Heat or Steam Sterilization

[03596010581716]

Moist Heat or Steam Sterilization

[03596010581716]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-09-07
• Device Publish Date: 2015-09-28

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• 00885556918036 - Trigen: 2024-04-18 8MM END CUTTING REAMER HEAD
• 00885556918043 - Trigen: 2024-04-18 8.5MM END CUTTING REAMER HEAD
• 00885556918050 - Polar: 2024-04-18 POLAR CALCAR PLANER - 40MM
• 00885556918067 - Polar: 2024-04-18 POLAR CALCAR PLANER - 45MM
• 00885556918029 - Trigen: 2024-04-16 DRILL SLEEVE DEPTH GAUGE
• 00885556917978 - Legion: 2024-04-10 EM PROXIMAL GUIDE - L