IOL Glide - Sheets

FDA UDI

Class I (US FDA UDI)

by Hurricane Medical

Identity

Trade Name: IOL Glide - Sheets FDA UDI
Generic Name: Manual intraocular lens injector, single-use FDA UDI
Device Name: Placement of intraocular lens into the posterior chamber. Also protects iris from prolapse or trauma during surgical procedures. Thickness 6 mil. End radius 2.5 mm. FDA UDI
Model / Reference: 9204 FDA UDI
Description: Placement of intraocular lens into the posterior chamber. Also protects iris from prolapse or trauma during surgical procedures. Thickness 6 mil. End radius 2.5 mm. FDA UDI

Identifiers

Catalog Number: 9204 FDA UDI
Primary DI / UDI-DI: 00813465012101 FDA UDI
FDA Product Code: KYB FDA UDI
GMDN Term: Manual intraocular lens injector, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 35 Millimeter FDA UDI
Width — 5 Millimeter FDA UDI

Category: Manual intraocular lens injector, single-use

IOL Glide - Sheets by Hurricane Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Hurricane Medical

Sources (1)

FDA UDI 7c3abe98-2632-42d6-8456-6aff449912d1 35 fields · synced Jun 6, 2026