FDA.report

Porges Coloplast

Primary DI
03600040323915
Brand
Porges Coloplast
Company
Coloplast A/S
Model
ACP405
Catalog number
ACP405
Device description
Ureteric catheter for guidewire0.038” (0.97 mm) / Open Coudé tip / 2 eyes / metal stylet / radiopaque / CH FR 4.8
Published
2019-04-20
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
EYBCATHETER, URETERAL, GASTRO-UROLOGY

Product Code Classifications

CodeDeviceSpecialtyClass
EYBCatheter, Ureteral, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03600040323915PackageGS15In Commercial Distribution
03600040323908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03600040323915036000403239153600040323915
03600040323908036000403239083600040323908

GMDN Terms

TermDefinition
Ureteral catheterA flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge4.8French

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store away from light in a cool and dry place

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)258-3476urology@coloplast.com

Regulatory Flags

DUNS number
305524696
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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