Titanium Chalazion Forceps, Round 25mm

Basic Information

• Brand Name: Titanium Chalazion Forceps, Round 25mm
• Primary DI: 00817489028117
• Version / Model: 3100-R25
• Company Name: KATALYST SURGICAL LLC
• Labeler DUNS: 007883297
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-28
• Public Version: 2
• Public Version Date: 2019-07-12
• Public Version Status: Update
• Public Device Record Key: ade9fb3f-9bf9-4dd1-8ff7-1b7ebbcdd511

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
HNR	Forceps, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62674	Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable	A hand-held manual surgical instrument designed to facilitate the grasping, manipulation, or clamping of, and/or removal of foreign bodies from, ophthalmic soft-tissues (ocular tissues, eyelids), and may be pointed for capsulorhexis. It has a conventional (self-opening) or reverse-action (self-closing) tweezers-like design with variously designed tips, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles); it is not probe-like in design (i.e., not cannulated). It is typically made of metal, available in various sizes, and may have carbide inserts at the working end. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817489028117	GS1