FDA.reportPublic FDA data

LoFric Origo

Primary DI
07333387059778
Brand
LoFric Origo
Company
Wellspect AB
Model
44016
Catalog number
4401600
Device description
Single Use Urinary Catheter with salt solution. LoFric Origo Pro Coudé Sleeve FX Male 40cm CH16 / Coudé FX 16" 16FR, Sterile device.
Published
2026-08-28
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
07333387060309PackageGS130In Commercial Distribution
07333387060316PackageGS14In Commercial Distribution
07333387060392PackageGS15In Commercial Distribution
07333387059778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333387060309073333870603097333387060309
07333387060316073333870603167333387060316
07333387060392073333870603927333387060392
07333387059778073333870597787333387059778

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 Gauge0
Catheter Length0

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
351118942
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
07333387059730LoFric Origo4401244012002026-08-28
07333387059754LoFric Origo4401444014002026-08-28
07333387060446Surity Power Adapter380394038039402026-09-28
07333387055299Surity Urinary Management System380014038001402026-08-18
07333387055305Surity Urinary Management Refresh Kit380024038002402026-08-18
07333387059198Surity Urinary Management System with Battery380034038003402026-08-18
07333387055367Surity Suction Tube380314038031402026-07-13
07333387055398Surity Carbon Filters380344038034402026-07-13
07333387055695LoFric Elle Pro41910502026-05-20
07333387055725LoFric Elle Pro41912502026-05-20
07333387055756LoFric Elle Pro41914502026-05-20
07333387056623Surity Male External Catheter3802138021402026-04-27
07333387056630Surity Female External Catheter3801138011402025-12-19
07333387055329Surity Female External Catheter38011380112025-12-19
07333387053110LoFric® Origo™4491244912402025-11-24
07333387053127LoFric® Origo™4491444914402025-11-24
07333387053134LoFric® Origo™4491644916402025-11-24
07333387054537LoFric® Origo™4491244912402025-11-24
07333387054575LoFric® Origo™4491444914402025-11-24
07333387054605LoFric® Origo™4491644916402025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05701780348317Luja SoftColoplast A/SEZD2026-10-01
05701780348348Luja SoftColoplast A/SEZD2026-10-01
05701780348379Luja SoftColoplast A/SEZD2026-10-01
05701780348409Luja SoftColoplast A/SEZD2026-10-01
07333387059730LoFric OrigoWellspect ABEZD2026-08-28
07333387059754LoFric OrigoWellspect ABEZD2026-08-28
00610075096121VaProHOLLISTER INCORPORATEDEZD2026-08-13
00610075096138VaProHOLLISTER INCORPORATEDEZD2026-08-13
00610075096145VaProHOLLISTER INCORPORATEDEZD2026-08-13
00610075096152VaProHOLLISTER INCORPORATEDEZD2026-06-06
00610075096169VaProHOLLISTER INCORPORATEDEZD2026-06-06
00610075096176VaProHOLLISTER INCORPORATEDEZD2026-06-06
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