Symmetry TUBBS

Basic Information

• Brand Name: Symmetry TUBBS
• Primary DI: 00887482080757
• Version / Model: 55-0870
• Catalog Number: 55-0870
• Company Name: SYMMETRY SURGICAL INC.
• Labeler DUNS: 079641356
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 9737234c-b264-4df7-8ace-9376148f6ce1
• Distribution End Date: 9999-01-01

Device Description

MITRAL VALVE Dilator

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: Yes
• PM Exempt: Yes
• 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
DWP	Dilator, Vessel, Surgical	Cardiovascular	870.4475	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11255	Mitral valve dilator	A hand-operated surgical instrument with specially designed expanding blades designed to dilate mitral stenosis during mitral valve surgery. It typically has forceps-like handles that include an adjustable, self-retaining mechanism to hold the blades at the desired expanded position. It is typically made of high-grade stainless steel and is available in various sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887482080757	GS1