VIRTUOSEW™ 023050

GUDID 10850012846281

VIRTUOSEW™ DEVICE

LSI Solutions, Inc.

Suturing unit, single-use

• Primary Device ID: 10850012846281
• NIH Device Record Key: f950633b-df56-4fcb-b096-84b90e3d339e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIRTUOSEW™
• Version Model Number: 023050
• Catalog Number: 023050
• Company DUNS: 603420183
• Company Name: LSI Solutions, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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
• 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	00850012846284 [Primary]
GS1	10850012846281 [Package]; Contains: 00850012846284; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222783

FDA Product Code

• GCJ: Laparoscope, 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: 2024-02-22
• Device Publish Date: 2024-02-14

Devices Manufactured by LSI Solutions, Inc.

• 00850012846376 - multiSTATION™: 2024-11-25 10mm COUPLER
• 10850200006497 - SEW-EASY®: 2024-10-29 SEW-EASY® COMBO KIT, 5mm
• 10850200006503 - SEW-EASY®: 2024-10-29 SEW-EASY® COMBO KIT, 3.5mm
• 10850200006510 - SEW-EASY®: 2024-10-29 SEW-EASY® DEVICE KIT, 5mm
• 10850200006527 - SEW-EASY®: 2024-10-29 SEW-EASY® DEVICE KIT, 3.5mm
• 00850012846253 - multiSTATION™: 2024-10-07 DOC-X 15™ EXTENDER
• 00850012846352 - multiSTATION™: 2024-10-07 DOC-X 25™ EXTENDER
• 00850012846369 - multiSTATION™: 2024-10-07 DOC-X 45™ EXTENDER