FDA.reportPublic FDA data

LoFric® Sense™

Primary DI
07392532180156
Brand
LoFric® Sense™
Company
Dentsply Ih AB
Model
4161450
Catalog number
4161450
Device description
Single Use Urinary Catheter LoFric Sense Nelaton 15cm CH14 / Nelaton 6" 14FR
Published
2016-11-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZDCATHETER, STRAIGHT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZDCatheter, StraightGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07392532086571PackageGS130In Commercial Distribution
07392532180156PackageGS14In Commercial Distribution
07392532086564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07392532086571073925320865717392532086571
07392532180156073925321801567392532180156
07392532086564073925320865647392532086564

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral catheterization kit, single-useA sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge14French
Length6Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place at room temperature.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)456-3742info-lofric-usa@wellspect.com

Regulatory Flags#

DUNS number
354059073
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333387029023Navina™Consumable Set Cone6901669016402023-09-01
07392532208461LoFric® Elle™418102541810052022-04-01
07392532208492LoFric® Elle™418122541812052022-04-01
07392532208522LoFric® Elle™418142541814052022-04-01
07392532274305LoFric® Elle™418105041810502022-04-01
07392532274336LoFric® Elle™418125041812502022-04-01
07392532274367LoFric® Elle™418145041814502022-04-01
07392532247255LoFric® Hydro-Kit™42008420084032020-12-04
07392532247279LoFric® Hydro-Kit™42010420104032020-12-04
07392532247316LoFric® Hydro-Kit™42012420124032020-12-04
07392532247347LoFric® Hydro-Kit™42014420144032020-12-04
07392532247361LoFric® Hydro-Kit™42016420164032020-12-04
07392532247408LoFric® Hydro-Kit™42018420184032020-12-04
07392532247439LoFric® Hydro-Kit™42108421084032020-12-04
07392532247453LoFric® Hydro-Kit™42110421104032020-12-04
07392532247491LoFric® Hydro-Kit™42308423084032020-12-04
07392532247521LoFric® Hydro-Kit™42310423104032020-12-04
07392532247576LoFric® Hydro-Kit™42312423124032020-12-04
07392532247606LoFric® Hydro-Kit™42314423144032020-12-04
07392532247637LoFric® Hydro-Kit™42316423164032020-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344162031MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-10-20
10197344162178MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-10-14
10197344162024MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162048MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162055MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162062MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162079MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162116MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162123MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162130MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162147MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162154MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162161MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162185MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162192MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162208MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162215MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162222MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162239MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162246MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162253MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162260MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162277MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162284MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10704411008828AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008835AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008842AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008859AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008873AMSure®HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008880AMSure®HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02