Dila-Cath Nelaton 40cm CH16

Basic Information

• Brand Name: Dila-Cath Nelaton 40cm CH16
• Primary DI: 07392532131707
• Version / Model: 40616
• Catalog Number: 4061600
• Company Name: Wellspect AB
• Labeler DUNS: 351118942
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-13
• Public Version: 5
• Public Version Date: 2023-06-15
• Public Version Status: Update
• Public Device Record Key: b186522b-e857-4987-85cc-47a8b55a0d7a
• Distribution End Date: 2023-06-15

Device Description

Urinary catheter for intermittent dilatation

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: Yes
• 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
FBX	SOUND, URETHRAL, METAL OR PLASTIC	Gastroenterology, Urology	876.5520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32022	Urethral dilatation catheter, non-medicated	A sterile, flexible or semi-flexible tube intended to be inserted into the urethra to open or increase the diameter of a constricted or irregular urethral passage. The device is typically made of plastic and silicone materials and is available in a variety of designs whereby: 1) it may have a larger diameter than that of a normal urethra; 2) it may have an attached inflatable balloon; or 3) the leading end of the device may be moulded into an extremely slender or thread-shaped form in order to facilitate passage of a larger, following portion; it does not elute a drug. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07392532129490	GS1		2	Not in Commercial Distribution	2023-06-14
Package	07392532088117	GS1		30	Not in Commercial Distribution	2023-06-14
Primary	07392532131707	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	40	Centimeter
Catheter Gauge	16	French

Storage Conditions

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