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DeRoyal

FDA UDI

Class I (US FDA UDI)

by Deroyal Industries, Inc.

Identity

Trade Name
DeRoyal FDA UDI
Generic Name
Surgical patient preparation kit FDA UDI
Device Name
LS DRY PREP TRAY W/LG WG SP MC FDA UDI
Model / Reference
50-10753 FDA UDI
Description
LS DRY PREP TRAY W/LG WG SP MC FDA UDI

Identifiers

Catalog Number
50-10753 FDA UDI
Primary DI / UDI-DI
00749756120388 FDA UDI
FDA Product Code
KDD FDA UDI
GMDN Term
Surgical patient preparation kit 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

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: Surgical patient preparation kit

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

Similar devices

Also classified as Surgical patient preparation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 7eede1f8-e247-4dce-a8ef-51a04078276c 35 fields · synced Jun 8, 2026