Symmetry Surgical®

Basic Information

• Brand Name: Symmetry Surgical®
• Primary DI: 00887482116371
• Version / Model: 62-0013
• Catalog Number: 62-0013
• Company Name: SYMMETRY SURGICAL INC.
• Labeler DUNS: 079641356
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-25
• Public Version: 1
• Public Version Date: 2018-10-26
• Public Version Status: New
• Public Device Record Key: 44659f10-a869-4154-a428-21302631b7b3
• Distribution End Date: 9999-01-01

Device Description

Symmetry® Magnifier, Aural Bruening Diagnostic Head

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: 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
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	882.4800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46550	Spectacle-mounted magnifier	A magnifying ophthalmic lens designed to be attached to a pair of spectacles and intended to enlarge text/images for a visually impaired patient/person. It is also known as a magnifying glass and can be made of solid plastic material or glass within a plastic or metal frame.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887482116371	GS1

Premarket Submissions

Submission Number	Supplement Number
K071771	000