DeRoyal

FDA UDI

Class II (US FDA UDI)

by Deroyal Industries, Inc.

Identity

Trade Name: DeRoyal FDA UDI
Generic Name: Angiographic syringe FDA UDI
Device Name: Control Syringe, 10CC, Male Rotator FDA UDI
Model / Reference: SY-1014 FDA UDI
Description: Control Syringe, 10CC, Male Rotator FDA UDI

Identifiers

Catalog Number: SY-1014 FDA UDI
Primary DI / UDI-DI: 00749756802802 FDA UDI
FDA Product Code: DXT FDA UDI
GMDN Term: Angiographic syringe FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1650 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

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

Yes

FDA UDI

Category: Angiographic syringe

DeRoyal by Deroyal Industries, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Deroyal Industries, Inc.

Sources (1)

FDA UDI b94b5952-ce7b-4336-9667-361219061a65 35 fields · synced Jun 8, 2026