ReTrace

Basic Information

• Brand Name: ReTrace
• Primary DI: 03600040995273
• Version / Model: ASXL10
• Catalog Number: ASXL10
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-20
• Public Version: 1
• Public Version Date: 2024-11-28
• Public Version Status: New
• Public Device Record Key: b80ae2a7-c75c-447c-a51f-895023a9afbd

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FED	endoscopic access overtube, gastroenterology-urology	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64309	Ureteral introduction sheath	A flexible tube intended to be used for ureteral access to allow introduction of other instruments (e.g., endoscope, catheter) and/or for guidewire exchange during a urological procedure. It may be intended for ureteral access via transurethral and/or percutaneous approach, and typically includes an inner dilator; it is however not a full introduction set. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03600040995280	GS1	Retail Box	1	In Commercial Distribution
Primary	03600040995273	GS1
Package	03600040995297	GS1	Shipper Box	24	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Sheath Outer Diameter - CH/FR 12
Device Size Text, specify			Sheath Length - cm 28
Device Size Text, specify			Sheath Inner Diameter - CH/FR 10

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.