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

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