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
• 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
• 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
• 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.

• 00850012846482 - multiSTATION™: 2025-09-08 TriFLEX™
• 10850012846533 - BOBsnare Device: 2025-08-29 BOBsnare Device
• 10850012846540 - RAM® COR-SUTURE® QUICK LOAD®: 2025-08-05 RAM® COR-SUTURE® QUICK LOAD® 6-TRAY 5MM NON-PLGT 2-0 POLYESTER, (3) GREEN and (3) WHITE
• 10850012846434 - PicoDriver: 2025-07-28 PicoDriver Device
• 10850012846465 - RAPORT™ KIT: 2025-07-17 RAPORT™ KIT RP-75™
• 10850012846472 - RAPORT™ KIT: 2025-07-17 RAPORT™ KIT RP-100™
• 10850012846526 - RD® QUICK LOAD®: 2025-07-17 RD® QUICK LOAD® SUTURE, 2-0 MONOGLIDE® DUO
• 10850012846458 - JNW URTRAC: 2025-06-16JNW URTRAC INSTRUMENT GUIDE
• 10850012846458 - JNW URTRAC: 2025-06-16 JNW URTRAC INSTRUMENT GUIDE