FDA.reportPublic FDA data

Porges Coloplast

Primary DI
03600040310892
Brand
Porges Coloplast
Company
Coloplast A/S
Model
ACXL12
Catalog number
ACXL12
Device description
Retrace Ureteral Accesss Sheath 35cm
Published
2019-07-16
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
FEDendoscopic access overtube, gastroenterology-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140523000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140523000RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CMColoplast A/S2014-07-24FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03600040310892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03600040310892036000403108923600040310892

GMDN Terms#

Term, Definition table
TermDefinition
Ureteral sheathA flexible tube intended to be inserted via the urethra and bladder into the ureter to gain access to the urinary tract and to provide a conduit for the passage of other instruments (e.g., endoscope, guidewire, catheter) during a urological procedure. It is typically inserted using a guidewire and/or dilator. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French
Catheter Gauge14French

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
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
05708932588942Freedom Clear5057415057412022-12-06
05708932957847Freedom Clear5057315057312022-12-06
05708932125338SpeediCath Flex Coude Pro20012200122019-07-12
05708932125369SpeediCath Flex Coude Pro20014200142019-07-12
05701780348317Luja Soft20171201712026-10-01
05701780348348Luja Soft20172201722026-10-01
05701780348379Luja Soft20174201742026-10-01
05701780348409Luja Soft20176201762026-10-01
05701780265058Biatain Adhesive348834882026-08-27
05708932787109Titan PrimeDS3918DS39182026-08-14
05708932787116Titan PrimeDS3920DS39202026-08-14
05708932787123Titan PrimeDS3922DS39222026-08-14
05708932787130Titan Prime5400055400052026-08-14
05708932787147Titan Prime5400105400102026-08-14
05708932787888Titan Prime5400155400152026-08-14
05708932787925Titan Prime5400205400202026-08-14
05708932787963Titan Prime5400255400252026-08-14
05708932788007Titan Prime5400305400302026-08-14
05708932788045Titan Prime5400405400402026-08-14
05708932788083Titan Prime5400505400502026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013645120Prodeon Urethral Sheath SystemProdeon Medical, Inc.FED2026-10-07
00191506062514Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062521Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062538Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062545Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062552Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062569Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062576Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062583Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
00191506062590Navigator™BOSTON SCIENTIFIC CORPORATIONFED2026-09-25
06942804744602Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744619Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744626Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744633Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744640Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744657Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744664Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744671Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744688Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744695Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744701Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744718Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744725Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744732Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744749Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744756Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744763Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744770Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744787Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22
06942804744794Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., LTD.FED2026-09-22