NaviBluTM Angled/Straight Dual Flexible:Nitinol Wire Hydrophilic Tips 0.035inch

Basic Information

• Brand Name: NaviBluTM Angled/Straight Dual Flexible:Nitinol Wire Hydrophilic Tips 0.035inch
• Primary DI: 03700512966104
• Version / Model: 09-0006
• Catalog Number: ROWR3501ST
• Company Name: Promepla
• Labeler DUNS: 401020409
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-09
• Public Version: 3
• Public Version Date: 2019-02-07
• Public Version Status: Update
• Public Device Record Key: 21f2a8d7-d45e-418f-9bc4-b561f8877b9a

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: 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
EYA	Stylet, Ureteral	Gastroenterology, Urology	876.5130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34926	Ureteral catheter	A flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03700512986102	GS1	Box	6	In Commercial Distribution
Package	03700512976103	GS1	Box	10	In Commercial Distribution
Primary	03700512966104	GS1

Customer Contacts

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