JNW URTRAC 081300

GUDID 10850012846458

JNW URTRAC INSTRUMENT GUIDE

LSI Solutions, Inc.

Endoscope sheath, single-use

• Primary Device ID: 10850012846458
• NIH Device Record Key: e88ac6e0-9ae6-4cf1-9950-4f2e7ddd54ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JNW URTRAC
• Version Model Number: 081300
• Catalog Number: 081300
• Company DUNS: 603420183
• Company Name: LSI Solutions, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850012846451 [Primary]
GS1	10850012846458 [Package]; Contains: 00850012846451; Package: Case [6 Units]; In Commercial Distribution

FDA Product Code

• GEA: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-16
• Device Publish Date: 2025-06-06

Devices Manufactured by LSI Solutions, Inc.

• 10850012846458 - JNW URTRAC: 2025-06-16JNW URTRAC INSTRUMENT GUIDE
• 10850012846458 - JNW URTRAC: 2025-06-16 JNW URTRAC INSTRUMENT GUIDE
• 10850012846427 - COR-KNOT MICRO: 2025-05-12 COR-KNOT® MICRO Twin Pack
• 00850012846277 - multiSTATION™: 2025-05-05 multiSTATION™ ARTICULATING ADAPTER
• 00850012846383 - multiSTATION™: 2025-03-12 LITA RetroSterno™ Paddle
• 00850012846390 - multiSTATION™: 2025-03-12 RITA RetroSterno™ Paddle
• 00850012846406 - multiSTATION™: 2025-02-07 Cannula Adapter
• 00850012846413 - multiSTATION™: 2025-02-07 5MM Cannula with Obturator
• 00850012846376 - multiSTATION™: 2024-11-25 10mm COUPLER