ACCESS 15 7205797

GUDID 03596010441522

REMOTE CONTROL ACCESS 15 PUMP

Smith & Nephew, Inc.

Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control

• Primary Device ID: 03596010441522
• NIH Device Record Key: 0a2aaa42-3339-4d45-8bd2-eda5dda8ed42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCESS 15
• Version Model Number: 7205797
• Catalog Number: 7205797
• 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: false
• Serial Number: true
• 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010441522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000153

FDA Product Code

• HRX: ARTHROSCOPE

Sterilization

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

[03596010441522]

Moist Heat or Steam Sterilization

[03596010441522]

Moist Heat or Steam Sterilization

[03596010441522]

Moist Heat or Steam Sterilization

[03596010441522]

Moist Heat or Steam Sterilization

[03596010441522]

Moist Heat or Steam Sterilization

[03596010441522]

Moist Heat or Steam Sterilization

[03596010441522]

Moist Heat or Steam Sterilization

[03596010441522]

Moist Heat or Steam Sterilization

[03596010441522]

Moist Heat or Steam Sterilization

[03596010441522]

Moist Heat or Steam Sterilization

[03596010441522]

Moist Heat or Steam Sterilization

[03596010441522]

Moist Heat or Steam Sterilization

[03596010441522]

Moist Heat or Steam Sterilization

[03596010441522]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-23

On-Brand Devices [ACCESS 15]

• 03596010441546: PUMP CART ACCESS 15 PUMP
• 03596010441522: REMOTE CONTROL ACCESS 15 PUMP