SVELTEFELT™ QUICK PLEDGE™ 082010

GUDID 10850012846687

SVELTEFELT™ QUICK PLEDGE™ UNIT

LSI Solutions, Inc.

Suture/ligature tightener, single-use

• Primary Device ID: 10850012846687
• NIH Device Record Key: 6ef77789-431e-40cb-9f3f-2a07478d7bdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SVELTEFELT™ QUICK PLEDGE™
• Version Model Number: 082010
• Catalog Number: 082010
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850012846680 [Primary]
GS1	10850012846687 [Package]; Contains: 00850012846680; Package: Case [6 Units]; In Commercial Distribution

FDA Product Code

• KGS: RETENTION DEVICE, SUTURE

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: 2026-01-29
• Device Publish Date: 2026-01-21

Devices Manufactured by LSI Solutions, Inc.

• 00850012846673 - multiSTATION® ViewSite™ Retractor: 2026-01-29 multiSTATION® ViewSite™ Retractor
• 10850012846687 - SVELTEFELT™ QUICK PLEDGE™: 2026-01-29SVELTEFELT™ QUICK PLEDGE™ UNIT
• 10850012846687 - SVELTEFELT™ QUICK PLEDGE™: 2026-01-29 SVELTEFELT™ QUICK PLEDGE™ UNIT
• 10850012846519 - C1® DEPTH LIMITER: 2025-12-16 C1® DEPTH LIMITER
• 10850012846656 - COR-KNOT MICRO: 2025-12-16 COR-KNOT MICRO® XL
• 10850012846663 - COR-KNOT MICRO: 2025-12-16 COR-KNOT MICRO® XL DEVICE TWIN PACK
• 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