Apellis Injection Kit

FDA UDI

Class II (US FDA UDI)

by Altaviz, LLC

Identity

Trade Name: Apellis Injection Kit FDA UDI
Generic Name: Ophthalmic needle, single-use FDA UDI
Device Name: Intravitreal Injection Kit with filter needle and injection needle FDA UDI
Model / Reference: IVT-KIT-29GE FDA UDI
Description: Intravitreal Injection Kit with filter needle and injection needle FDA UDI

Identifiers

Catalog Number: IVT-KIT-29GE FDA UDI
Primary DI / UDI-DI: 00860008043689 FDA UDI
510(k) Number: K231261 FDA UDI
FDA Product Code: FMI FDA UDI
GAA FDA UDI
GMDN Term: Ophthalmic needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 FDA UDI
878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 29 Gauge FDA UDI
Length — .5 Inch FDA UDI

Category: Ophthalmic needle, single-use

Apellis Injection Kit by Altaviz, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic needle, single-use.

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Needle aspiration and injection — Katena Products, Inc. · Class I
Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
OMNI Edge Surgical System — Sight Sciences, Inc. · Class II
Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
Walcott Rx Products — Psi/Eye-Ko, Inc. · Class I

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 II	Pending data

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Manufacturer

Manufacturer: Altaviz, LLC

Sources (1)

FDA UDI 3912ad6b-b284-4539-b027-b0ec10956c63 36 fields · synced May 30, 2026