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Relieva Luma Sentry

FDA UDI

Class I (US FDA UDI)

by Acclarent, Inc.

Identity

Trade Name
RELIEVA LUMA SENTRY FDA UDI
Generic Name
Paranasal sinus-illumination light guide cable FDA UDI
Device Name
RELIEVA LUMA SENTRY SINUS ILLUMINATION SYSTEM FDA UDI
Model / Reference
SIS100B FDA UDI
Description
RELIEVA LUMA SENTRY SINUS ILLUMINATION SYSTEM FDA UDI

Identifiers

Catalog Number
SIS100B FDA UDI
Primary DI / UDI-DI
10705031135635 FDA UDI
510(k) Number
K071845 FDA UDI
FDA Product Code
KAM FDA UDI
GMDN Term
Paranasal sinus-illumination light guide cable 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

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Paranasal sinus-illumination light guide cable

Relieva Luma Sentry by Acclarent, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Paranasal sinus-illumination light guide cable.

Cleared under the same submission

K071845 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Acclarent, Inc.

Sources (1)

  • FDA UDI f4953e61-72fc-4f5f-a3b7-9052780b7da5 37 fields · synced May 30, 2026