FDA.reportPublic FDA data

Porges Coloplast

Primary DI
03600040324189
Brand
Porges Coloplast
Company
Coloplast A/S
Model
ACR206
Catalog number
ACR206
Device description
Floppy Tip Hydro-Coated Ureteric Catheter for guidewire 0.035" (0.89mm)/ 70 cm / CH/FR 06
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
03600040324189PackageGS15In Commercial Distribution
03600040324172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03600040324189036000403241893600040324189
03600040324172036000403241723600040324172

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, 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
05708932778268SpeediCath Flex Set28941289412026-02-05
05708932778275SpeediCath Flex Set28942289422026-02-05
05708932778282SpeediCath Flex Set28946289462026-02-05
03600040963876ColoplastAC5904AC59042026-01-30
03600040963944ColoplastAC5905AC59052026-01-30
03600040964026ColoplastAC5906AC59062026-01-30
03600040964095ColoplastAC5907AC59072026-01-30
03600040964170ColoplastAC5908AC59082026-01-30
03600040964231ColoplastAC5909AC59092026-01-30
03600040964293ColoplastAC5910AC59102026-01-30
03600040964361ColoplastAC5911AC59112026-01-30
03600040964415ColoplastAC5912AC59122026-01-30
03600040964651ColoplastAC5C07AC5C072026-01-30
03600040965894ColoplastACP205ACP2052026-01-30
03600040965948ColoplastACP206ACP2062026-01-30
03600040966006ColoplastACP207ACP2072026-01-30
03600040966068ColoplastACP208ACP2082026-01-30
03600040966136ColoplastACP303ACP3032026-01-30
03600040966228ColoplastACP304ACP3042026-01-30
03600040966310ColoplastACP305ACP3052026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03600040963876ColoplastColoplast A/SEYB2026-01-30
03600040963944ColoplastColoplast A/SEYB2026-01-30
03600040964026ColoplastColoplast A/SEYB2026-01-30
03600040964095ColoplastColoplast A/SEYB2026-01-30
03600040964170ColoplastColoplast A/SEYB2026-01-30
03600040964231ColoplastColoplast A/SEYB2026-01-30
03600040964293ColoplastColoplast A/SEYB2026-01-30
03600040964361ColoplastColoplast A/SEYB2026-01-30
03600040964415ColoplastColoplast A/SEYB2026-01-30
03600040964651ColoplastColoplast A/SEYB2026-01-30
03600040965894ColoplastColoplast A/SEYB2026-01-30
03600040965948ColoplastColoplast A/SEYB2026-01-30
03600040966006ColoplastColoplast A/SEYB2026-01-30
03600040966068ColoplastColoplast A/SEYB2026-01-30
03600040966136ColoplastColoplast A/SEYB2026-01-30
03600040966228ColoplastColoplast A/SEYB2026-01-30
03600040966310ColoplastColoplast A/SEYB2026-01-30
03600040966402ColoplastColoplast A/SEYB2026-01-30
03600040966488ColoplastColoplast A/SEYB2026-01-30
03600040966549ColoplastColoplast A/SEYB2026-01-30
03600040966600ColoplastColoplast A/SEYB2026-01-30
03600040966662ColoplastColoplast A/SEYB2026-01-30
03600040966730ColoplastColoplast A/SEYB2026-01-30
03600040966792ColoplastColoplast A/SEYB2026-01-30
03600040966846ColoplastColoplast A/SEYB2026-01-30
03600040966914ColoplastColoplast A/SEYB2026-01-30
03600040967003ColoplastColoplast A/SEYB2026-01-30
03600040967058ColoplastColoplast A/SEYB2026-01-30
03600040967157ColoplastColoplast A/SEYB2026-01-30
03600040967218ColoplastColoplast A/SEYB2026-01-30