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.

• 00885556921715 - LEGION: 2025-04-18 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 5-6 12MM
• 00885556922569 - LEGION: 2025-04-18 LEGION MEDIAL STABILIZED TRIAL INSERT W/JRNY LCK LEFT SZ 7-8 12MM
• 00885556922194 - LEGION: 2025-04-15 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK LEFT SZ 1-2 9MM
• 00885556922217 - LEGION: 2025-04-15 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK LEFT SZ 1-2 10MM
• 00885556905470 - NA: 2025-03-12 VARIABLE ANGLE VALGUS GUIDE
• 00885556880876 - EVOS: 2025-02-28 EVOS 2.7MM STAGGERED PATELLA PLATE
• 00885556880883 - EVOS: 2025-02-28 EVOS 2.7MM SPLIT PATELLA PLATE
• 00885556886403 - EVOS: 2025-02-28 EVOS 2.7MM MESH PATELLA PLATE - SMALL