Stealth Surgical

Basic Information

• Brand Name: Stealth Surgical
• Primary DI: 00888515291201
• Version / Model: SSG85793
• Catalog Number: SSG85793
• Company Name: BOSS INSTRUMENTS, LTD., INC.
• Labeler DUNS: 848522678
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: b4ec145c-2c4e-4c0a-8312-966c0c6e6154

Device Description

CLOWARD STYLE BODY ONLY HINGED FRAME

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: No
• Has Manufacturing Date: No
• 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
13384	Laminectomy retractor, self-retaining	A self-locking, surgical instrument, used for separating the edges or drawing aside the margins of a surgical incision to permit excision of the lamina of the vertebral posterior arch; this can be necessary to expose a portion of the spinal cord for removal of a tumour, relief of pressure due to a fracture, or disc protrusion. The instrument may resemble a large pair of scissors with wide-angle blades which have fenestrated curved hooks, often terminating in sharp points, at the distal end to grasp the tissues. It is usually made of stainless steel and comes in a variety of designs. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888515291201	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]