FDA.report

LoFric® Origo™

Primary DI
07392532154331
Brand
LoFric® Origo™
Company
Dentsply Ih AB
Model
44414
Catalog number
44414
Device description
Single Use Urinary Catheter with salt solution. LoFric Origo, Tiemann 40cm CH14 / Coudé 16" 14FR, Sterile device.
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

Related Records

Contact Domains

Product Codes

CodeName
EZDCATHETER, STRAIGHT

Product Code Classifications

CodeDeviceSpecialtyClass
EZDCatheter, StraightGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07392532154324PackageGS130In Commercial Distribution
07392532154331PackageGS14In Commercial Distribution
07392532183164PackageGS15In Commercial Distribution
07392532122576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07392532154324073925321543247392532154324
07392532154331073925321543317392532154331
07392532183164073925321831647392532183164
07392532122576073925321225767392532122576

GMDN Terms

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

TypeValueUnit
Catheter Gauge14French
Length16Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place at room temperature

Sterilization Methods

Method

Contacts

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

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