C1® DEPTH LIMITER

Basic Information

• Brand Name: C1® DEPTH LIMITER
• Primary DI: 00850200006896
• 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: 2020-03-13
• Public Version: 3
• Public Version Date: 2022-11-10
• Public Version Status: Update
• Public Device Record Key: 19027be8-4fba-4870-bd0c-03fda9e3abac

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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
Primary	00850200006896	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K100593	000

Device Sizes

Type	Value	Unit	Text
Width	11	Millimeter