FDA.reportPublic FDA data

LoFric® Origo™

Primary DI
07392532156236
Brand
LoFric® Origo™
Company
Dentsply Ih AB
Model
44208
Catalog number
44208
Device description
Single Use Urinary Catheter with salt solution. LoFric Origo, Nelaton 30cm CH08 / Nelaton 12" 08FR, Sterile device.
Published
2017-01-20
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
07392532156229PackageGS130In Commercial Distribution
07392532156236PackageGS14In Commercial Distribution
07392532186660PackageGS15In Commercial Distribution
07392532122477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07392532156229073925321562297392532156229
07392532156236073925321562367392532156236
07392532186660073925321866607392532186660
07392532122477073925321224777392532122477

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
Length12Inch

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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10197344162260MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
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10197344162284MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
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10704411008859AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
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10704411008880AMSure®HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02