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Relieva Flex

FDA UDI

Class I (US FDA UDI)

by Acclarent, Inc.

Identity

Trade Name
RELIEVA FLEX FDA UDI
Generic Name
Paranasal sinus guide-catheter FDA UDI
Device Name
RELIEVA FLEX SINUS GUIDE CATHETER M-110, 1 PK FDA UDI
Model / Reference
GC110RFZ FDA UDI
Description
RELIEVA FLEX SINUS GUIDE CATHETER M-110, 1 PK FDA UDI

Identifiers

Catalog Number
GC110RFZ FDA UDI
Primary DI / UDI-DI
20705031063263 FDA UDI
FDA Product Code
KAM FDA UDI
GMDN Term
Paranasal sinus guide-catheter 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

Yes

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 guide-catheter

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

Similar devices

Also classified as Paranasal sinus guide-catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Acclarent, Inc.

Sources (1)

  • FDA UDI 9787b5dc-e6c1-4834-be79-7c1357c8bc4e 36 fields · synced Jun 1, 2026