SEW-EASY® 022797

GUDID 10850200006497

SEW-EASY® COMBO KIT, 5mm

LSI Solutions, Inc.

Suturing unit, single-use

• Primary Device ID: 10850200006497
• NIH Device Record Key: 1e461b5a-8829-4829-83da-74797bcf5a6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEW-EASY®
• Version Model Number: 022797
• Catalog Number: 022797
• 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
• 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	00850200006490 [Primary]
GS1	10850200006497 [Package]; Contains: 00850200006490; Package: Case [3 Units]; In Commercial Distribution

FDA Product Code

• DWS: INSTRUMENTS, SURGICAL, CARDIOVASCULAR

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: 2024-10-29
• Device Publish Date: 2024-10-21

On-Brand Devices [SEW-EASY®]

• 10850200006886: SEW-EASY® SNARE
• 10850200006640: SEW-EASY® DEVICE 5.0 KIT
• 10850200006633: SEW-EASY® DEVICE 5.0 COMBO KIT
• 10850200006541: SEW-EASY® M DEVICE
• 10850200006527: SEW-EASY® DEVICE KIT, 3.5mm
• 10850200006510: SEW-EASY® DEVICE KIT, 5mm
• 10850200006503: SEW-EASY® COMBO KIT, 3.5mm
• 10850200006497: SEW-EASY® COMBO KIT, 5mm