FDA.report

Dila-Cath Nelaton 40cm CH18

Primary DI
07333387041018
Brand
Dila-Cath Nelaton 40cm CH18
Company
Wellspect AB
Model
40618
Catalog number
4061800
Device description
Urinary catheter for intermittent dilatation
Published
2023-06-01
Public version status
New
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
FBXSOUND, URETHRAL, METAL OR PLASTIC

Product Code Classifications

CodeDeviceSpecialtyClass
FBXSound, Urethral, Metal Or PlasticGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07333387041001PackageGS12In Commercial Distribution
07333387041018PackageGS130In Commercial Distribution
07392532135323PreviousGS10
07333387040998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07333387041001073333870410017333387041001
07333387041018073333870410187333387041018
07392532135323073925321353237392532135323
07333387040998073333870409987333387040998

GMDN Terms

TermDefinition
Urethral dilatation catheter, non-medicatedA sterile, flexible or semi-flexible tube intended to be inserted into the urethra to open or increase the diameter of a constricted or irregular urethral passage. The device is typically made of plastic and silicone materials and is available in a variety of designs whereby: 1) it may have a larger diameter than that of a normal urethra; 2) it may have an attached inflatable balloon; or 3) the leading end of the device may be moulded into an extremely slender or thread-shaped form in order to facilitate passage of a larger, following portion; it does not elute a drug. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge18French
Length40Centimeter

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
351118942
Device count
1
DM exempt
false
Premarket exempt
true
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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