FDA.reportPublic FDA data

Coloplast

Primary DI
03600040966389
Brand
Coloplast
Company
Coloplast A/S
Model
ACP306
Catalog number
ACP306
Published
2026-01-30
Public version status
New
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
EYBCATHETER, URETERAL, GASTRO-UROLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYBCatheter, Ureteral, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03600040966396PackageGS15In Commercial Distribution
03600040966402PackageGS159In Commercial Distribution
03600040966389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03600040966396036000409663963600040966396
03600040966402036000409664023600040966402
03600040966389036000409663893600040966389

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.

Contacts#

Phone, Email table
PhoneEmail
+1(800)258-3476urology@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708932135184Conveen05050050502023-01-17
05701780434133SenSura Mio1229101229102026-04-30
05701780434508SenSura Mio1229201229202026-04-30
05701780434843SenSura Mio1229601229602026-04-30
05701780435239SenSura Mio1229701229702026-04-30
05701780436328SenSura Mio Convex1367901367902026-04-30
05701780436977SenSura Mio Convex1373101373102026-04-30
05701780437066SenSura Mio Convex1373201373202026-04-30
05701780437127SenSura Mio Convex1373301373302026-04-30
05701780437561SenSura Mio Convex1680101680102026-04-30
05701780438384SenSura Mio Convex1680501680502026-04-30
05701780439923SenSura Mio Convex1682101682102026-04-30
05701780440462SenSura Mio Convex1682201682202026-04-30
05701780440875SenSura Mio Convex1682301682302026-04-30
05701780441292SenSura Mio Convex1682501682502026-04-30
05701780441926SenSura Mio Convex1682601682602026-04-30
05701780442572SenSura Mio Convex1682701682702026-04-30
05701780443074SenSura Mio Convex1683001683002026-04-30
05701780443371SenSura Mio Convex1683101683102026-04-30
05701780444026SenSura Mio Convex1683201683202026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03600040963869ColoplastColoplast A/SEYB2026-01-30
03600040963920ColoplastColoplast A/SEYB2026-01-30
03600040964019ColoplastColoplast A/SEYB2026-01-30
03600040964071ColoplastColoplast A/SEYB2026-01-30
03600040964163ColoplastColoplast A/SEYB2026-01-30
03600040964224ColoplastColoplast A/SEYB2026-01-30
03600040964286ColoplastColoplast A/SEYB2026-01-30
03600040964347ColoplastColoplast A/SEYB2026-01-30
03600040964408ColoplastColoplast A/SEYB2026-01-30
03600040964644ColoplastColoplast A/SEYB2026-01-30
03600040965870ColoplastColoplast A/SEYB2026-01-30
03600040965931ColoplastColoplast A/SEYB2026-01-30
03600040965993ColoplastColoplast A/SEYB2026-01-30
03600040966051ColoplastColoplast A/SEYB2026-01-30
03600040966112ColoplastColoplast A/SEYB2026-01-30
03600040966204ColoplastColoplast A/SEYB2026-01-30
03600040966297ColoplastColoplast A/SEYB2026-01-30
03600040966471ColoplastColoplast A/SEYB2026-01-30
03600040966532ColoplastColoplast A/SEYB2026-01-30
03600040966594ColoplastColoplast A/SEYB2026-01-30
03600040966655ColoplastColoplast A/SEYB2026-01-30
03600040966716ColoplastColoplast A/SEYB2026-01-30
03600040966778ColoplastColoplast A/SEYB2026-01-30
03600040966839ColoplastColoplast A/SEYB2026-01-30
03600040966891ColoplastColoplast A/SEYB2026-01-30
03600040966983ColoplastColoplast A/SEYB2026-01-30
03600040967041ColoplastColoplast A/SEYB2026-01-30
03600040967133ColoplastColoplast A/SEYB2026-01-30
03600040967195ColoplastColoplast A/SEYB2026-01-30
03600040967256ColoplastColoplast A/SEYB2026-01-30