Alatus

FDA UDI

Class II (US FDA UDI)

by Radiadyne, L.l.c.

Identity

Trade Name: Alatus FDA UDI
Generic Name: Vaginal speculum, single-use FDA UDI
Device Name: Alatus Vaginal Balloon Packing System Kit FDA UDI
Model / Reference: ALA-45 Unit Tray FDA UDI
Description: Alatus Vaginal Balloon Packing System Kit FDA UDI

Identifiers

Catalog Number: ALA-45 FDA UDI
Primary DI / UDI-DI: 00851546007004 FDA UDI
510(k) Number: K092534 FDA UDI
FDA Product Code: IYE FDA UDI
JAQ FDA UDI
GMDN Term: Vaginal speculum, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5050 FDA UDI
892.5700 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

MRI Safety

MR Conditional FDA UDI

Category: Vaginal speculum, single-use

Alatus by Radiadyne, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K092534 also covers:

Alatus — ANGIODYNAMICS, INC

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: Radiadyne, L.l.c.

Sources (1)

FDA UDI 4afb0d97-9885-4eb8-a113-734f27136882 36 fields · synced Jun 1, 2026