LoFric® Elle™ 4181050

GUDID 07333387023908

Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH10 / Nelaton 4" 10FR

Wellspect AB

Intermittent urethral drainage catheter, non-antimicrobial, single-use
Primary Device ID07333387023908
NIH Device Record Keyae45ac44-5bf0-4180-8b5c-5129577d0b11
Commercial Distribution StatusIn Commercial Distribution
Brand NameLoFric® Elle™
Version Model Number4181050
Catalog Number4181050
Company DUNS351118942
Company NameWellspect AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)4563742
Emailinfo-lofric-usa@wellspect.com

Device Dimensions

Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French
Catheter Length4 Inch
Catheter Gauge10 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS107333387023892 [Primary]
GS107333387023908 [Package]
Contains: 07333387023892
Package: [30 Units]
In Commercial Distribution
GS107333387023915 [Package]
Package: [2 Units]
In Commercial Distribution
GS107392532274282 [Previous]

FDA Product Code

EZDCatheter, straight

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-03
Device Publish Date2023-09-25

On-Brand Devices [LoFric® Elle™]

07333387024608Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR
07333387024455Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR 5-pack
07333387024288Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH12 / Nelaton 4" 12FR
07333387024080Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH12 / Nelaton 4" 12FR 5-pack
07333387023908Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH10 / Nelaton 4" 10FR
07333387023755Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH10 / Nelaton 4" 10FR 5-pack

Trademark Results [LoFric]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LOFRIC
LOFRIC
73423764 1324299 Live/Registered
Astra Meditec Aktiebolag
1983-04-29

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