C1® DEPTH LIMITER 022012

GUDID 00850200006896

C1® DEPTH LIMITER

LSI Solutions, Inc.

Suturing unit depth limiter

• Primary Device ID: 00850200006896
• NIH Device Record Key: 19027be8-4fba-4870-bd0c-03fda9e3abac
• 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: true
• 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: false
• Lot Batch: true
• Serial Number: true
• 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

Device Dimensions

• Width: 11 Millimeter
• Width: 11 Millimeter
• Width: 11 Millimeter
• Width: 11 Millimeter
• Width: 11 Millimeter
• Width: 11 Millimeter
• Width: 11 Millimeter
• Width: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850200006896 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100593

FDA Product Code

• HCF: INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00850200006896]

Moist Heat or Steam Sterilization

[00850200006896]

Moist Heat or Steam Sterilization

[00850200006896]

Moist Heat or Steam Sterilization

[00850200006896]

Moist Heat or Steam Sterilization

[00850200006896]

Moist Heat or Steam Sterilization

[00850200006896]

Moist Heat or Steam Sterilization

[00850200006896]

Moist Heat or Steam Sterilization

[00850200006896]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-30
• Device Publish Date: 2020-03-13

On-Brand Devices [C1® DEPTH LIMITER]

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