STRADIS

Basic Information

• Brand Name: STRADIS
• Primary DI: M75267182EBA1
• Version / Model: 6718-2EBA
• Company Name: STRADIS MEDICAL, LLC
• Labeler DUNS: 174262477
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-01
• Public Version: 4
• Public Version Date: 2022-04-01
• Public Version Status: Update
• Public Device Record Key: ea4d46cb-5598-4cd6-ab45-99807b49e96d
• Distribution End Date: 2022-03-31

Device Description

STERILE SEPARATE 18.0 TREPHINE

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32822	Corneal trephine manual instrument	A hand-held, ophthalmic surgical instrument, constructed as a one-piece handle with trephine (not an exchangeable component) that is manually rotated with downward pressure by a surgeon in order to cut and remove circular pieces of corneal tissue (corneal buttons). The trephine portion consists of a shaft that has at its working end an extremely sharp, bevelled, cylindrical cutting edge. Healthy tissue may be taken from cadavers for transplant to the recipient, where the defect cornea is cut and removed for acceptance of the replacement. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M75267182EBA1	HIBCC

Customer Contacts

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