KIT, US LENS Integrated System 72204863

GUDID 00885556617915

KIT US LENS INTEGRATED SYSTEM

Smith & Nephew, Inc.

Endoscopic video imaging system

• Primary Device ID: 00885556617915
• NIH Device Record Key: cc9fc4c2-f664-4a45-96fe-fdfdfa13b7bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIT, US LENS Integrated System
• Version Model Number: 72204863
• Catalog Number: 72204863
• 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: true
• 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
• 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	00885556617915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153606

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-13

Devices Manufactured by Smith & Nephew, Inc.

• 00885556414965 - REFLECTION: 2025-12-11 REFLECTION XLPE 36MM INNER DIAMETER 0 DEGREE 54-56MM OUTER DIAMETER SIZE F ETO
• 00885556533574 - REFLECTION: 2025-12-11 REFLECTION XLPE 36MM INNER DIAMETER 0 DEGREE 66-68MM OUTER DIAMETER SIZE J ETO
• 00885556533581 - REFLECTION: 2025-12-11 REFLECTION XLPE 36MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F ETO
• 00885556535059 - REFLECTION: 2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE ANTEVERTED +4MM 50-52MM OUTER DIAMETER E ETO
• 00885556535073 - REFLECTION: 2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E ETO
• 00885556535080 - REFLECTION: 2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F ETO
• 00885556535097 - REFLECTION: 2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETERSIZE G ETO
• 00885556535103 - REFLECTION: 2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 62-64MM OUTER DIAMETER SIZE H ETO