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DeRoyal

FDA UDI

Class I (US FDA UDI)

by Deroyal Industries, Inc.

Identity

Trade Name
DeRoyal FDA UDI
Generic Name
Sharp surgical instrument counting tray/pad, single-use FDA UDI
Device Name
Simplicity® Sharps System FDA UDI
Model / Reference
25-0900NS FDA UDI
Description
Simplicity® Sharps System FDA UDI

Identifiers

Catalog Number
25-0900NS FDA UDI
Primary DI / UDI-DI
00749756779746 FDA UDI
FDA Product Code
KDC FDA UDI
GMDN Term
Sharp surgical instrument counting tray/pad, single-use 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

No

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: Sharp surgical instrument counting tray/pad, single-use

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

Similar devices

Also classified as Sharp surgical instrument counting tray/pad, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 2f2314c6-3f15-4c93-b0f3-2a6af8ef8f0e 35 fields · synced Jun 8, 2026