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DeRoyal

FDA UDI

Class II (US FDA UDI)

by Deroyal Industries, Inc.

Identity

Trade Name
DeRoyal FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
CCASC LAPAROTOMY PACK PGYBK FDA UDI
Model / Reference
89-10558 FDA UDI
Description
CCASC LAPAROTOMY PACK PGYBK FDA UDI

Identifiers

Catalog Number
89-10558 FDA UDI
Primary DI / UDI-DI
00749756364430 FDA UDI
FDA Product Code
LRO FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General surgical procedure kit, non-medicated, single-use

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

Similar devices

Also classified as General surgical procedure kit, non-medicated, single-use.

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 8d8ccfc4-e6d4-48c5-a272-f09f9e5ca74b 35 fields · synced Jun 8, 2026