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Regard™

FDA UDI

Class I (US FDA UDI)

by Resource Optimization & Innovation, L.l.c.

Identity

Trade Name
Regard™ FDA UDI
Generic Name
Surgical instrument interim-placement holder, single-use FDA UDI
Model / Reference
70512ROI FDA UDI

Identifiers

Primary DI / UDI-DI
30326053102685 FDA UDI
FDA Product Code
GAB FDA UDI
GMDN Term
Surgical instrument interim-placement holder, 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Category: Surgical instrument interim-placement holder, single-use

Regard™ by Resource Optimization & Innovation, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument interim-placement holder, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Resource Optimization & Innovation, L.l.c.

Sources (1)

  • FDA UDI 600fa183-f62d-4af5-adac-89a61e6d9e11 32 fields · synced May 30, 2026