FDA.reportPublic FDA data

LoFric® Primo™

Primary DI
07392532098550
Brand
LoFric® Primo™
Company
Dentsply Ih AB
Model
41318
Catalog number
4131840
Device description
Single Use Urinary Catheter LoFric Primo Nelaton 8" 18FR
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
07392532098543PackageGS130In Commercial Distribution
07392532098550PackageGS14In Commercial Distribution
07392532135507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07392532098543073925320985437392532098543
07392532098550073925320985507392532098550
07392532135507073925321355077392532135507

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 Gauge18French
Length8Inch

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
50850058254451EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
00850058254463EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254475EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
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
20197344162021MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162045MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162052MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162069MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162076MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162113MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162120MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162137MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162144MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162151MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162168MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162182MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162199MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22