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Regard™

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name
Regard™ FDA UDI
Generic Name
Ophthalmic surgical drape FDA UDI
Device Name
DRAPE INCS 15X15IN OPTH LF STRL FDA UDI
Model / Reference
DRP1-15X15ST-REG FDA UDI
Description
DRAPE INCS 15X15IN OPTH LF STRL FDA UDI

Identifiers

Catalog Number
DRP1-15X15ST-REG FDA UDI
Primary DI / UDI-DI
00326053120633 FDA UDI
FDA Product Code
HMT FDA UDI
GMDN Term
Ophthalmic surgical drape 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

No

FDA UDI

Over-the-Counter

Yes

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: Ophthalmic surgical drape

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

Similar devices

Also classified as Ophthalmic surgical drape.

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 dfb5d683-7cfa-415a-abc2-fa0a33087587 34 fields · synced May 30, 2026