'SL-PLUS¿/INTEGRATION-PLUS¿' 75000178

GUDID 07611996092806

SL-PLUS INTEGR MIA STEM WITH TI/HA 5

Smith & Nephew, Inc.

Coated hip femur prosthesis, modular

• Primary Device ID: 07611996092806
• NIH Device Record Key: 29d6ee41-b3cd-44ab-9bf8-a65ee1331cd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 'SL-PLUS¿/INTEGRATION-PLUS¿'
• Version Model Number: 75000178
• Catalog Number: 75000178
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
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Device Identifiers

Device Issuing Agency	Device ID
GS1	07611996092806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122296

FDA Product Code

• LWJ: Prosthesis, hip, semi-constrained, metal/polymer, uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29