← Back to catalogue

DeRoyal

FDA UDI

Class II (US FDA UDI)

by Deroyal Industries, Inc.

Identity

Trade Name
DeRoyal FDA UDI
Generic Name
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
LAPAROSCOPIC GYN ROBOTICTRACECART® FDA UDI
Model / Reference
53-1958 FDA UDI
Description
LAPAROSCOPIC GYN ROBOTICTRACECART® FDA UDI

Identifiers

Catalog Number
53-1958 FDA UDI
Primary DI / UDI-DI
00749756997379 FDA UDI
FDA Product Code
OHD FDA UDI
GMDN Term
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1720 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

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

Yes

FDA UDI

Category: Obstetrical/gynaecological 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 Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Deroyal Industries, Inc.

Sources (1)

  • FDA UDI a7a0af16-564d-407b-b189-5e3178767d8f 35 fields · synced Jun 8, 2026