Curved Lowsley

Basic Information

• Brand Name: Curved Lowsley
• Primary DI: 00821925005082
• Version / Model: 437
• Company Name: Gyrus Acmi, Inc.
• Labeler DUNS: 007198742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-12
• Public Version: 5
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: ff0945d2-f4dc-4540-b063-48aa081359fc

Device Description

Curved Lowsley Tractor Single-Action, Stem Only 21.5 Fr (7.1 mm) With 10.5 Inch (267 mm) Working Length

Device Characteristics

• Single Use: No
• 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: 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOB	CATHETER, SUPRAPUBIC (AND ACCESSORIES)	Gastroenterology, Urology	876.5090	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32021	Suprapubic catheter introducer, reusable	A rigid surgical instrument(s) intended to gain percutaneous suprapubic access to the urinary bladder, via the lower abdominal wall, for placement of a drainage catheter (not included). It includes a sharp pointed trocar blade and/or a suprapubic access cannula/sleeve, and is typically made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00821925005082	GS1

Premarket Submissions

Submission Number	Supplement Number
K012153	000