DEVICE: LoFric® Elle™ (07392532274343)

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Device Record History
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Device Identifier (DI) Information
LoFric® Elle™
4181450
Not in Commercial Distribution
4181450
Wellspect AB
07392532274343
GS1
March 31, 2024
1
351118942 *Terms of Use
Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
EZD CATHETER, STRAIGHT
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a dry place at room temperature.
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 14 French
Catheter Length: 4 Inch
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Device Record Status
e3d2554e-6514-4583-abd5-52ab59741f72
April 01, 2024
4
April 01, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
07392532274367 2 07392532274350 2024-03-30 Not in Commercial Distribution
07392532274350 30 07392532274343 2024-03-30 Not in Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)4563742
info-lofric-usa@wellspect.com
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