Resonance

Basic Information

• Brand Name: Resonance
• Primary DI: 10827002341125
• Version / Model: G34112
• Catalog Number: RMS-060028-R
• Company Name: COOK IRELAND LTD
• Labeler DUNS: 988559035
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 1bc77cbb-b8e7-43b1-9d0c-fd7cb3074655

Device Description

Resonance, Metallic Ureteral Stent and Introducer

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: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FAD	STENT, URETERAL	Gastroenterology, Urology	876.4620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58004	Bare-metal ureteral stent	A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder; it is often used to treat ureteric obstruction caused by external compression (e.g., from malignancy). It may be a mesh structure or a continuous tube and is made entirely of metal; it may be expandable in situ (e.g., self-expands) and deployment and/or removal devices are typically included (e.g., catheter, guidewire, suture). The device is typically intended for long-term, but not permanent, implantation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10827002341125	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dark, dry location away from temperature extremes