N/A

Basic Information

• Brand Name: N/A
• Primary DI: 10818255010456
• Version / Model: N/A
• Catalog Number: 5127
• Company Name: MICROVISION, INC.
• Labeler DUNS: 013486803
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2018-04-04
• Public Version: 1
• Public Version Date: 2018-05-07
• Public Version Status: New
• Public Device Record Key: 7814697a-6c59-44fb-b1b1-18c5f959f4ed

Device Description

Reusable Flexible Iris Retractors

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: 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
10906	Eyeball tissue retractor, reusable	An ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of tissues of the eyeball (e.g., iris, sclera) during ophthalmic surgery. It may be a hand-held hook-like device or a self-retaining device. It is typically made of high-grade stainless steel. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10818255010456	GS1
Unit of Use	00818255010459	GS1

Device Sizes

Type	Value	Unit	Text
Length	9.0	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Caution
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from direct sunlight