Disposable Iris Retractor Hooks

Basic Information

• Brand Name: Disposable Iris Retractor Hooks
• Primary DI: 00817489026267
• Version / Model: D4176-5
• Company Name: KATALYST SURGICAL LLC
• Labeler DUNS: 007883297
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-28
• Public Version: 1
• Public Version Date: 2025-05-06
• Public Version Status: New
• Public Device Record Key: 14abda6b-66b8-46cf-af71-52aeb566e5ae

Device Description

Disposable Iris Retractor Hooks

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
HNI	Retractor, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46698	Intraocular retractor, single-use	A sterile, dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a self-retaining ring/frame or a small hook-like device which may include a retention bead, and is usually designed to be manipulated using another ophthalmic instrument. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817489026267	GS1
Package	10817489026264	GS1	Pack of Hooks	5	In Commercial Distribution
Package	20817489026261	GS1	Pack of Hooks	2	In Commercial Distribution