FDA.reportPublic FDA data

Porges Coloplast

Primary DI
03600040324998
Brand
Porges Coloplast
Company
Coloplast A/S
Model
RF3017
Catalog number
RF3017
Device description
Amplatz Sheath 30Ch/Fr - 17cm long
Published
2021-01-22
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
LJECATHETER, NEPHROSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJECatheter, NephrostomyUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03600040324998PackageGS15In Commercial Distribution
03600040324981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03600040324998036000403249983600040324998
03600040324981036000403249813600040324981

GMDN Terms#

Term, Definition table
TermDefinition
Nephrostomy sheathA flexible or rigid tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract to maintain a nephrostomy tract for the passage of other instruments (e.g., endoscope, guidewire, catheter); it is not a nephrostomy catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge30French
Length17Centimeter

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
00860000917506RetroPercRETROPERC INC.LJE2025-01-09
05701780270878KolibriColoplast A/SLJE2023-01-20
05701780270908KolibriColoplast A/SLJE2023-01-20
05701780270939KolibriColoplast A/SLJE2023-01-20
05701780270977KolibriColoplast A/SLJE2023-01-20
05701780271042KolibriColoplast A/SLJE2023-01-20
05701780271066KolibriColoplast A/SLJE2023-01-20
05701780271097KolibriColoplast A/SLJE2023-01-20
05701780271127KolibriColoplast A/SLJE2023-01-20
05701780271165KolibriColoplast A/SLJE2023-01-20
05701780271189KolibriColoplast A/SLJE2023-01-20
05701780271219KolibriColoplast A/SLJE2023-01-20
05701780271240KolibriColoplast A/SLJE2023-01-20
05701780271271KolibriColoplast A/SLJE2023-01-20
05701780271318KolibriColoplast A/SLJE2023-01-20
05701780271332KolibriColoplast A/SLJE2023-01-20
05701780271363KolibriColoplast A/SLJE2023-01-20
05701780271417KolibriColoplast A/SLJE2023-01-20
05701780271448KolibriColoplast A/SLJE2023-01-20
05701780271462KolibriColoplast A/SLJE2023-01-20
05701780271509KolibriColoplast A/SLJE2023-01-20
05701780271547KolibriColoplast A/SLJE2023-01-20
05701780271592KolibriColoplast A/SLJE2023-01-20
05701780271622KolibriColoplast A/SLJE2023-01-20
05701780271646KolibriColoplast A/SLJE2023-01-20
05701780271677KolibriColoplast A/SLJE2023-01-20
05701780271714KolibriColoplast A/SLJE2023-01-20
05701780271745KolibriColoplast A/SLJE2023-01-20
05701780271783KolibriColoplast A/SLJE2023-01-20
05701780271813KolibriColoplast A/SLJE2023-01-20