LoFric® Elle™

Basic Information

• Brand Name: LoFric® Elle™
• Primary DI: 07333387024202
• Version / Model: 4181225
• Catalog Number: 4181205
• 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: 30875380-eb2f-47c2-a100-9c2591e2bc58

Device Description

Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH12 / Nelaton 4" 12FR 5-pack

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	07333387024080	GS1		5	In Commercial Distribution
Primary	07333387024202	GS1
Previous	07392532235399	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Length	4	Inch
Catheter Gauge	12	French

Storage Conditions

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