FDA.report

LoFric®

Primary DI
07392532097232
Brand
LoFric®
Company
Dentsply Ih AB
Model
40108
Catalog number
4010840
Device description
Single Use Urinary Catheter LoFric Nelaton 8" 08FR Paediatric
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
07392532097225PackageGS130In Commercial Distribution
07392532097232PackageGS14In Commercial Distribution
07392532135217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07392532097225073925320972257392532097225
07392532097232073925320972327392532097232
07392532135217073925321352177392532135217

GMDN Terms

TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge8French
Length8Inch

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
true
Sterilization required before use
false

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