FDA.reportPublic FDA data

Coloplast

Primary DI
03600040975312
Brand
Coloplast
Company
Coloplast A/S
Model
RBD010
Catalog number
RBD010
Published
2024-07-09
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
EZNDILATOR, CATHETER, URETERAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03600040975329PackageGS110In Commercial Distribution
03600040975336PackageGS124In Commercial Distribution
03600040975312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03600040975329036000409753293600040975329
03600040975336036000409753363600040975336
03600040975312036000409753123600040975312

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
Catheter Gauge10French

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
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
03600040255728Porges ColoplastColoplast A/SEZN2019-06-30
03600040255773Porges ColoplastColoplast A/SEZN2019-06-30