FDA.reportPublic FDA data

Porges Coloplast

Primary DI
03600040324219
Brand
Porges Coloplast
Company
Coloplast A/S
Model
ACR207
Catalog number
ACR207
Device description
Floppy Tip Hydro-Coated Ureteric Catheter for guidewire 0.035" (0.89mm)/ 70 cm / CH/FR 07
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

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
03600040324219PackageGS15In Commercial Distribution
03600040324202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03600040324219036000403242193600040324219
03600040324202036000403242023600040324202

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 Gauge7French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store away from light in a cool and dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

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

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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
03600040966389ColoplastColoplast 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