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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
Woven gauze pad, non-antimicrobial FDA UDI
Device Name
SPONGE GAUZE 4X4IN GAUZE RAYON POLYESTER 6 PLY HIGH ABSORBENT DRAIN TUBE LOW LINT LATEX FREE STERILE FDA UDI
Model / Reference
GASPG4X4P6-REG FDA UDI
Description
SPONGE GAUZE 4X4IN GAUZE RAYON POLYESTER 6 PLY HIGH ABSORBENT DRAIN TUBE LOW LINT LATEX FREE STERILE FDA UDI

Identifiers

Catalog Number
GASPG4X4P6-REG FDA UDI
Primary DI / UDI-DI
00326053120169 FDA UDI
FDA Product Code
NAB FDA UDI
GMDN Term
Woven gauze pad, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4014 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: Woven gauze pad, non-antimicrobial

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 Woven gauze pad, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI d833ff45-3d4d-4c66-85e0-5f36c2ad3685 34 fields · synced Jun 8, 2026