FDA.report

LoFric®

Primary DI
07392532097751
Brand
LoFric®
Company
Dentsply Ih AB
Model
40412
Catalog number
4041240
Device description
Single Use Urinary Catheter LoFric Nelaton 6" 12FR
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
07392532097744PackageGS130In Commercial Distribution
07392532097751PackageGS14In Commercial Distribution
07392532135309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07392532097744073925320977447392532097744
07392532097751073925320977517392532097751
07392532135309073925321353097392532135309

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 Gauge12French
Length6Inch

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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