ellacor

Basic Information

• Brand Name: ellacor
• Primary DI: B933ELCLP011
• Version / Model: EL-CLP01
• Catalog Number: EL-CLP01
• Company Name: Cytrellis Biosystems, Inc.
• Labeler DUNS: 078440636
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2024-01-03
• Public Version: 2
• Public Version Date: 2024-01-12
• Public Version Status: Update
• Public Device Record Key: 02ddc7d3-b425-4e50-91e0-c94e29c8763c

Device Description

Suction tubing clip

Device Characteristics

• Single Use: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QAI	Powered Microneedle Device	General, Plastic Surgery	878.4430	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64593	Medical/surgical interventional tube/cable securement clip, reusable	A device intended to hold, position, and organize medical/surgical interventional tubing (e.g., arterial/venous lines, gas lines, drainage catheters) or cables to an equipment, drape or gown; it is not intended to affix the tubing to the patient directly. It is typically designed as a clip or a block with clips. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B933ELCLP011	HIBCC
Unit of Use	B933ELCLP016	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K202517	000