LoFric® Elle™ 4181005

GUDID 07392532208461

Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH10 / Nelaton 4" 10FR 5-pack

Dentsply Ih AB

Intermittent urethral drainage catheter, non-antimicrobial, single-use
Primary Device ID07392532208461
NIH Device Record Key0bddfed3-92a7-4e9a-bf73-f30cc2179950
Commercial Distribution StatusIn Commercial Distribution
Brand NameLoFric® Elle™
Version Model Number4181025
Catalog Number4181005
Company DUNS354059073
Company NameDentsply Ih 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
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
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.
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
GS107392532208461 [Package]
Contains: 07392532235368
Package: [5 Units]
In Commercial Distribution
GS107392532235368 [Primary]

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 Date2022-04-11
Device Publish Date2022-04-01

On-Brand Devices [LoFric® Elle™]

07392532274367Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR
07392532274336Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH12 / Nelaton 4" 12FR
07392532274305Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH10 / Nelaton 4" 10FR
07392532208522Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR 5-pack
07392532208492Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH12 / Nelaton 4" 12FR 5-pack
07392532208461Single 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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