FDA.reportPublic FDA data

LoFric® Sense™

Primary DI
07392532183256
Brand
LoFric® Sense™
Company
Dentsply Ih AB
Model
4160825
Catalog number
4160805
Device description
Single Use Urinary Catheter with salt solution. LoFric Sense, Nelaton 15cm CH08 / Nelaton 6" 08FR, 5 pack. For females. Sterile device.
Published
2018-10-06
Public version status
New
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
07392532183256PackageGS15In Commercial Distribution
07392532085888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07392532183256073925321832567392532183256
07392532085888073925320858887392532085888

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 Gauge8French
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
false
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
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00850058254463EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
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50850058254482EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254499EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254505EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254512EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254529EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254536EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254543EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254550EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254567EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
05708932778275SpeediCath Flex SetColoplast A/SEZD2026-02-05
05708932778282SpeediCath Flex SetColoplast A/SEZD2026-02-05
07333387054537LoFric® Origo™Wellspect ABEZD2025-11-24
07333387054575LoFric® Origo™Wellspect ABEZD2025-11-24
07333387054605LoFric® Origo™Wellspect ABEZD2025-11-24
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