Dila-Cath Nelaton 40cm CH18

Primary DI
07333387040998
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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBXSOUND, URETHRAL, METAL OR PLASTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBXSound, Urethral, Metal Or PlasticGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333387041001PackageGS12In Commercial Distribution
07333387041018PackageGS130In Commercial Distribution
07392532135323PreviousGS10
07333387040998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333387041001073333870410017333387041001
07333387041018073333870410187333387041018
07392532135323073925321353237392532135323
07333387040998073333870409987333387040998

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge18French
Length40Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place at room temperature.

Contacts#

Phone, Email table
PhoneEmail
+1(877)456-3742info-lofric-usa@wellspect.com

Regulatory Flags#

DUNS number
351118942
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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