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Regard™

FDA UDI

Class II (US FDA UDI)

by Roi Cps, Llc

Identity

Trade Name
Regard™ FDA UDI
Generic Name
Laparoscopic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
PK CUST LAP CHOLE FDA UDI
Model / Reference
GS00237H FDA UDI
Description
PK CUST LAP CHOLE FDA UDI

Identifiers

Primary DI / UDI-DI
10194717112488 FDA UDI
FDA Product Code
FDE FDA UDI
GMDN Term
Laparoscopic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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: Laparoscopic surgical procedure kit, non-medicated, single-use

Regard™ by Roi Cps, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic 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
Roi Cps, Llc

Sources (1)

  • FDA UDI a292c902-2daf-4775-acc6-7c8269f758b4 33 fields · synced Jun 1, 2026