Set of 5 Iris Retractors

Basic Information

• Brand Name: Set of 5 Iris Retractors
• Primary DI: 08052276027061
• Version / Model: AK-0492
• Catalog Number: AK-0492
• Company Name: AKTIVE SRL
• Labeler DUNS: 433533053
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2024-01-11
• Public Version: 1
• Public Version Date: 2024-01-19
• Public Version Status: New
• Public Device Record Key: 1da531c5-6e84-4fce-b3f4-a981e57fadcd

Device Description

Set of 5 Iris Retractors

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HOC	Clip, Iris Retractor	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
Unit of Use	08056477550502	GS1
Primary	08052276027061	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			GAUGE

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius