FDA.reportPublic FDA data

Porges Coloplast

Primary DI
03600040255728
Brand
Porges Coloplast
Company
Coloplast A/S
Model
RBA008
Catalog number
RBA008
Device description
Percutaneous nephrostomy dilator CH FR 08
Published
2019-06-30
Public version status
Update
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
EZNDILATOR, CATHETER, URETERAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZNDilator, Catheter, UreteralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03600040255735PackageGS15In Commercial Distribution
03600040255728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03600040255735036000402557353600040255735
03600040255728036000402557283600040255728

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic-access dilator, single-useA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French

Storage And Handling#

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

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
05701780385411SenSura Mio Convex18541185412026-06-08
05701780385442SenSura Mio Convex18542185422026-06-08
05701780385473SenSura Mio Convex18543185432026-06-08
05701780385503SenSura Mio Convex18544185442026-06-08
05701780385541SenSura Mio Convex18545185452026-06-08
05701780385572SenSura Mio Convex18546185462026-06-08
05701780385602SenSura Mio Convex18547185472026-06-08
05701780385633SenSura Mio Convex18548185482026-06-08
05701780385664SenSura Mio Convex18549185492026-06-08
05701780385701SenSura Mio Convex18550185502026-06-08
05701780385732SenSura Mio Convex18551185512026-06-08
05701780385763SenSura Mio Convex18540185402026-06-08
05708932487047Peristeen29125291252016-09-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03600040975312ColoplastColoplast A/SEZN2024-07-09
03600040975343ColoplastColoplast A/SEZN2024-07-09
03600040975336ColoplastColoplast A/SEZN2024-07-09
03600040975367ColoplastColoplast A/SEZN2024-07-09
03600040911051ColoplastColoplast A/SEZN2024-05-21
03600040911082ColoplastColoplast A/SEZN2024-05-21
03600040953792ColoplastColoplast A/SEZN2024-05-21
03600040911068ColoplastColoplast A/SEZN2024-05-21
03600040911105ColoplastColoplast A/SEZN2024-05-21
03600040953808ColoplastColoplast A/SEZN2024-05-21
03600040953761ColoplastColoplast A/SEZN2024-05-10
03600040953785ColoplastColoplast A/SEZN2024-05-10
03600040953679ColoplastColoplast A/SEZN2024-04-12
03600040953709ColoplastColoplast A/SEZN2024-04-12
03600040953730ColoplastColoplast A/SEZN2024-04-12
03600040953693ColoplastColoplast A/SEZN2024-04-12
03600040953716ColoplastColoplast A/SEZN2024-04-12
03600040953747ColoplastColoplast A/SEZN2024-04-12
00812261012605ARMADAALLWIN MEDICAL DEVICES, INC.EZN2023-07-31
00812261012612ARMADAALLWIN MEDICAL DEVICES, INC.EZN2023-07-31
10812261012602ARMADAALLWIN MEDICAL DEVICES, INC.EZN2023-07-31
10812261012619ARMADAALLWIN MEDICAL DEVICES, INC.EZN2023-07-31
03600040325117Porges ColoplastColoplast A/SEZN2020-06-19
03600040325148Porges ColoplastColoplast A/SEZN2020-06-19
03600040325179Porges ColoplastColoplast A/SEZN2020-06-19
05708932727501Porges ColoplastColoplast A/SEZN2020-06-19
05708932727532Porges ColoplastColoplast A/SEZN2020-06-19
05708932727563Porges ColoplastColoplast A/SEZN2020-06-19
00827002150799Cook 810COOK INCORPORATEDEZN2019-11-26
03600040255773Porges ColoplastColoplast A/SEZN2019-06-30