ReTrace

Basic Information

• Brand Name: ReTrace
• Primary DI: 03600040995365
• Version / Model: AXXL12
• Catalog Number: AXXL12
• 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: 7fd50198-ffd8-4e4d-8977-5d335d9ddaff

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	03600040995389	GS1	Shipper Box	24	In Commercial Distribution
Package	03600040995372	GS1	Retail Box	1	In Commercial Distribution
Primary	03600040995365	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Sheath Length - cm 45
Device Size Text, specify			Sheath Inner Diameter - CH/FR 12
Device Size Text, specify			Sheath Outer Diameter - CH/FR 14

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.