← Back to catalogue

Regard™

FDA UDI

Class I (US FDA UDI)

by Roi Cps, Llc

Identity

Trade Name
Regard™ FDA UDI
Generic Name
ENT surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
SEPTO SINUS FDA UDI
Model / Reference
ET00701GH FDA UDI
Description
SEPTO SINUS FDA UDI

Identifiers

Primary DI / UDI-DI
10194717116028 FDA UDI
FDA Product Code
OGR FDA UDI
GMDN Term
ENT surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 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: ENT surgical procedure kit, non-medicated, single-use

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

Similar devices

Also classified as ENT 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
Roi Cps, Llc

Sources (1)

  • FDA UDI 29b0bbbf-856e-469a-bc7a-c2a91f1ffd4b 33 fields · synced Jun 8, 2026