RetroPerc

Basic Information

• Brand Name: RetroPerc
• Primary DI: 00860000917506
• Version / Model: RP91-01
• Catalog Number: RP91-01
• Company Name: RETROPERC INC.
• Labeler DUNS: 112165284
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-09
• Public Version: 1
• Public Version Date: 2025-01-17
• Public Version Status: New
• Public Device Record Key: 645c5258-22dc-4be7-9945-b14bf191baf5

Device Description

Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
LJE	Catheter, Nephrostomy	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
64235	Nephrostomy introduction sheath	A flexible or rigid tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract to maintain a nephrostomy tract for the introduction of other instruments (e.g., endoscope, guidewire, catheter); it is not a nephrostomy catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860000917506	GS1

Customer Contacts

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