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LabVit Kit

FDA UDI

Class I (US FDA UDI)

by Labtician Ophthalmics, Inc

Identity

Trade Name
LabVit Kit FDA UDI
Generic Name
General surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Disposable Intravitreal Injection Kit. FDA UDI
Model / Reference
LVK1000, LVK1100 FDA UDI
Description
Disposable Intravitreal Injection Kit. FDA UDI

Identifiers

Catalog Number
N/A FDA UDI
Primary DI / UDI-DI
10871321002526 FDA UDI
FDA Product Code
KDD FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General surgical procedure kit, non-medicated, reusable

LabVit Kit by Labtician Ophthalmics, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Labtician Ophthalmics, Inc

Sources (1)

  • FDA UDI 0b5598a3-6f9c-4a52-8852-933e02a51777 35 fields · synced Jun 1, 2026