CORNEAL TREPHINE HANDLE 9MM

Basic Information

• Brand Name: CORNEAL TREPHINE HANDLE 9MM
• Primary DI: 00841668142301
• Version / Model: AE-8211H
• Catalog Number: AE-8211H
• Company Name: KATENA PRODUCTS, INC.
• Labeler DUNS: 085668598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: af9287f4-8fff-4911-8915-3c71b5a67cfb

Device Description

CORNEAL TREPHINE HANDLE 9MM

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRH	Trephine, manual, ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46252	Corneal trephine handle	A hand-held, ophthalmic surgical device used to hold an exchangeable trephine (cylindrical cutting blade) so that it can be manually rotated with downward pressure by a surgeon in order to cut and remove circular pieces of corneal tissue (corneal buttons) or scleral tissue. It is typically made of high-grade stainless steel and may have a knurled portion on the shaft to provide a grip. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841668142301	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	9	Millimeter