Symmetry Surgical®

Basic Information

• Brand Name: Symmetry Surgical®
• Primary DI: 00887482173817
• Version / Model: 61-0396
• Catalog Number: 61-0396
• Company Name: ASPEN SURGICAL PRODUCTS, INC.
• Labeler DUNS: 027680821
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-12
• Public Version: 3
• Public Version Date: 2025-10-29
• Public Version Status: Update
• Public Device Record Key: 55024e6b-9d41-420e-ac85-42d1cd4d899a
• Distribution End Date: 2024-09-16

Device Description

Knife, House Incudostapedial Joint, Angled 20°, 0.5 mm x 1.5 mm Blade, 6 1/2 in

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
HTS	Knife, Orthopedic	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35143	Sternum knife	A heavy-duty, hand-held manual surgical instrument designed for cutting into the sternum (the breastbone). It typically has a T-shaped handle to allow the application of pressure to the blade which descends from the handle in a thick shaft terminating in various contours. It is typically made of high-grade stainless steel; its handle may be made of a synthetic polymer (e.g., Tufnol). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887482173817	GS1