FDA.report

Van Andel

Primary DI
00827002147126
Brand
Van Andel
Company
COOK INCORPORATED
Model
G14712
Catalog number
029109
Device description
Van Andel Catheter
Published
2016-09-24
Public version status
Update
Distribution status
Not 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
KODCATHETER, UROLOGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00827002147126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002147126008270021471268270021471260827002147126

GMDN Terms

TermDefinition
Ureteral dilatation/injection catheterA sterile, flexible or semi-flexible tube designed to be inserted through the urethra to open or increase the diameter of a constricted or irregular ureteral passage and allow the injection of a contrast medium to access possible submucosal tunnelling. The device is typically made of plastic materials and is available in a variety of diameters and lengths. It may also be used for the injection of a topical anaesthetic; other instruments may be passed through this device. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags

DUNS number
042823948
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
true
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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