C1® DEPTH LIMITER 022012

GUDID 10850012846519

C1® DEPTH LIMITER

LSI Solutions, Inc.

Suturing unit depth limiter

• Primary Device ID: 10850012846519
• NIH Device Record Key: c5705f4b-df54-42dc-89ba-4c571c0bd41c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C1® DEPTH LIMITER
• Version Model Number: 022012
• Catalog Number: 022012
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850012846512 [Primary]
GS1	00850200006896 [Previous]
GS1	10850012846519 [Package]; Contains: 00850012846512; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100593

FDA Product Code

• HCF: INSTRUMENT, LIGATURE PASSING AND KNOT TYING

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: 2025-12-16
• Device Publish Date: 2025-12-08

On-Brand Devices [C1® DEPTH LIMITER]

• 00850200006896: C1® DEPTH LIMITER
• 10850012846519: C1® DEPTH LIMITER