C1® DEPTH LIMITER

Basic Information

• Brand Name: C1® DEPTH LIMITER
• Primary DI: 00850012846512
• Version / Model: 022012
• Catalog Number: 022012
• Company Name: LSI Solutions, Inc.
• Labeler DUNS: 603420183
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-08
• Public Version: 1
• Public Version Date: 2025-12-16
• Public Version Status: New
• Public Device Record Key: c5705f4b-df54-42dc-89ba-4c571c0bd41c

Device Description

C1® DEPTH LIMITER

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HCF	INSTRUMENT, LIGATURE PASSING AND KNOT TYING	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64668	Suturing unit depth limiter	A non-powered device intended to limit the depth of tissue captured by a suture while a clinician is operating a suturing unit (suture/needle passer) [not included], typically during a minimally-invasive surgical procedure (e.g., introduction of an aortic cannula). It is typically in the form of clasp/clip attached to the distal end of the suturing unit. This is single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850012846519	GS1	Case	12	In Commercial Distribution
Primary	00850012846512	GS1
Previous	00850200006896	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K100593	000