LoFric® Elle™

Basic Information

• Brand Name: LoFric® Elle™
• Primary DI: 07333387024592
• Version / Model: 4181450
• Catalog Number: 4181450
• Company Name: Wellspect AB
• Labeler DUNS: 351118942
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-25
• Public Version: 2
• Public Version Date: 2023-10-06
• Public Version Status: Update
• Public Device Record Key: c16be9a2-8982-461a-9f63-e17587a41fe4

Device Description

Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EZD	Catheter, straight	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64266	Intermittent urethral drainage catheter, non-antimicrobial, single-use	A flexible or rigid tube designed for a single insertion into the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide urine drainage, typically for an individual who is physiologically incapable of voiding. The device is typically pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass] and is disposed of after use; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07333387024608	GS1		30	In Commercial Distribution
Primary	07333387024592	GS1
Package	07333387024615	GS1		2	In Commercial Distribution
Previous	07392532274343	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	14	French
Catheter Length	4	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry place at room temperature.