AccessGUDID - DEVICE: LoFric® Elle™ (07333387024530)

GUDID

Device Identifier (DI) Information

Brand Name: LoFric® Elle™
Version or Model: 4181425
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4181405
Company Name: Wellspect AB

Primary DI Number: 07333387024530
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 351118942 *Terms of Use
Previous DI: 07392532235429

Device Description: Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR 5-pack

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZD	Catheter, straight

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a dry place at room temperature.

Clinically Relevant Size

[?]

Size Type Text
Catheter Length: 4 Inch
Catheter Gauge: 14 French

Device Record Status

Public Device Record Key: 3eed507c-ce5c-4329-b356-e88163315d3d
Public Version Date: December 17, 2024
Public Version Number: 3
DI Record Publish Date: September 25, 2023