Symmetry Surgical®

Basic Information

• Brand Name: Symmetry Surgical®
• Primary DI: 00887482141915
• Version / Model: 55-9215
• Catalog Number: 55-9215
• Company Name: SYMMETRY SURGICAL INC.
• Labeler DUNS: 079641356
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-08
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 994f8870-323b-4b9f-9562-ac2638bf93d3
• Distribution End Date: 9999-01-01

Device Description

Endarterectomy Loops Set/6 Gauge 20,22,24,26,28&30

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
HRT	Stripper, Surgical	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35165	Endarterectomy loop	A hand-held manual surgical instrument intended to be used to grip and excise atherosclerotic deposits (i.e., thickened atheromatous tunica intima) from the lumen of an artery (i.e., endarterectomy). It will typically consist of a slender handle onto which a piece of flexible wire that ends in a small loop is attached or be used together with an endarterectomy loop puller. It is typically inserted percutaneously under radiographic guidance. It is 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	00887482141915	GS1