Device
Single Use Urinary Catheter LoFric Elle Pro Nelaton 10cm CH14 / Nelaton 4" 14FR
Manufacturer
Wellspect AB
Wellspect AB
Model: 4191450
DI: 07333387055756
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
Single Use Urinary Catheter LoFric Elle Pro Nelaton 10cm CH14 / Nelaton 4" 14FR
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7297056b-f340-4244-ac5c-8f96efb885a6
Distribution Status:
In Commercial Distribution
DUNS Number:
351118942
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Device ID:
07333387055770
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
2
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
07333387055763
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
07333387055763
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
30
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
07333387055756
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
07333387055756
Item #3 - Device ID Type:
Primary
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 64266
Name: Intermittent urethral drainage catheter, non-antimicrobial, single-use
Definition:
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.
FDA Product Codes
EZD
Catheter, straight
Device Sizes
Item #1 - Size - @attributes - Unit:
Inch
Item #1 - Size - @attributes - Value:
4
Item #1 - Size Type:
Catheter Length
Item #2 - Size - @attributes - Unit:
French
Item #2 - Size - @attributes - Value:
14
Item #2 - Size Type:
Catheter Gauge
Environmental Conditions
Storage Handling - Storage Handling Type:
Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text:
Store in a dry place at room temperature.