N.A.

Basic Information

• Brand Name: N.A.
• Primary DI: 04049368069591
• Version / Model: 18238
• Catalog Number: 18238
• Company Name: Geuder Aktiengesellschaft
• Labeler DUNS: 316267202
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-23
• Public Version: 1
• Public Version Date: 2021-03-03
• Public Version Status: New
• Public Device Record Key: 3e3cce58-7d8b-4298-ab4e-f8aecf481ab9

Device Description

N.A.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
HNJ	Punch, corneo-scleral	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47088	Corneal punch set	A collection of surgical instruments intended to cut a precise circular section of the cornea (corneal button) from stored cadaveric donor tissue for transplantation into a prepared patient. It typically consists of a small base plate, an extremely sharp and hollow cylinder that has a thin circular cutting edge (a trephine), and a guide through which the trephine can travel. The surgeon typically places a section of corneal tissue into the centre of the base plate (it has a graduated inverse bowl emulating the curvature of the eye), assembles the guide and trephine into position, and applies pressure onto the trephine to cut the button. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049368069591	GS1