FDA.reportPublic FDA data

Porges Coloplast

Primary DI
03600040322727
Brand
Porges Coloplast
Company
Coloplast A/S
Model
ALXL10
Catalog number
ALXL10
Device description
RETRACE® Ureteral Access Sheath, inner diameter CH FR 10, outer diameter CH FR 12, length 55 cm
Published
2019-07-16
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
FEDendoscopic access overtube, gastroenterology-urology

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03600040322727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03600040322727036000403227273600040322727

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 Gauge10French
Catheter Gauge12French

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
16925816667210ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
16925816667227ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
16925816667234ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
16970462547454Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547461Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547478Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547485Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547492Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547508Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547515Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547522Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547539Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547546Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547553Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547560Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547577Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547584Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547591Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547607Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547614Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16925816657518ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657525ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657532ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657549ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657556ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657563ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657570ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657587ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657594ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657600ClearPetraWell Lead Medical Co.,LtdFED2026-01-26