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DeRoyal

FDA UDI

Class II (US FDA UDI)

by Deroyal Industries, Inc.

Identity

Trade Name
DeRoyal FDA UDI
Generic Name
Pelvic examination kit FDA UDI
Device Name
PELVIC EXAM TRAY FDA UDI
Model / Reference
89-6219 FDA UDI
Description
PELVIC EXAM TRAY FDA UDI

Identifiers

Catalog Number
89-6219 FDA UDI
Primary DI / UDI-DI
00749756664387 FDA UDI
FDA Product Code
MLT FDA UDI
GMDN Term
Pelvic examination kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.4530 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

Yes

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

No

FDA UDI

Category: Pelvic examination kit

DeRoyal by Deroyal Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pelvic examination kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Deroyal Industries, Inc.

Sources (1)

  • FDA UDI 9d3e1b7d-88fd-4eb0-b0fa-d111fd527681 35 fields · synced Jun 8, 2026