Dila-Cath Nelaton 40cm CH18 4061800

GUDID 07392532088087

Urinary catheter for intermittent dilatation

Dentsply Ih AB

Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated
Primary Device ID07392532088087
NIH Device Record Keyc201b2a7-5819-4b7d-be44-95e3931caa96
Commercial Distribution StatusIn Commercial Distribution
Brand NameDila-Cath Nelaton 40cm CH18
Version Model Number40618
Catalog Number4061800
Company DUNS354059073
Company NameDentsply Ih AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com

Device Dimensions

Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter
Catheter Gauge18 French
Length40 Centimeter

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.
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
GS107392532088087 [Package]
Contains: 07392532088094
Package: Transport Packaging [2 Units]
In Commercial Distribution
GS107392532088094 [Package]
Contains: 07392532135323
Package: Customer Packaging [30 Units]
In Commercial Distribution
GS107392532135323 [Primary]

FDA Product Code

FBXSOUND, URETHRAL, METAL OR PLASTIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-23
Device Publish Date2019-12-13

Devices Manufactured by Dentsply Ih AB

07333387029023 - Navina™Consumable Set Cone2023-09-11 Navina Transanal Irrigation. Consumable set cone. 1 Water container, 15 Rectal catheters cone. Non Sterile device. Rx Only.
07392532208461 - LoFric® Elle™2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH10 / Nelaton 4" 10FR 5-pack
07392532208492 - LoFric® Elle™2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH12 / Nelaton 4" 12FR 5-pack
07392532208522 - LoFric® Elle™2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR 5-pack
07392532274305 - LoFric® Elle™2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH10 / Nelaton 4" 10FR
07392532274336 - LoFric® Elle™2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH12 / Nelaton 4" 12FR
07392532274367 - LoFric® Elle™2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR
07392532247255 - LoFric® Hydro-Kit™2020-12-14 Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 08FR
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