FDA.report

Porges Coloplast

Primary DI
03600040322666
Brand
Porges Coloplast
Company
Coloplast A/S
Model
ASXL10
Catalog number
ASXL10
Device description
RETRACE® Ureteral Access Sheath, inner diameter CH FR 10, outer diameter CH FR 12, length 28 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

Related Records

Contact Domains

Product Codes

CodeName
FEDendoscopic access overtube, gastroenterology-urology

Product Code Classifications

CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03600040322666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03600040322666036000403226663600040322666

GMDN Terms

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

TypeValueUnit
Catheter Gauge10French
Catheter Gauge12French

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store away from light in a cool and dry place

Sterilization Methods

Method

Contacts

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

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