Surgimedics®

FDA UDI

Class I (US FDA UDI)

by Coastal Life Technologies, Inc.

Identity

Trade Name: Surgimedics® FDA UDI
Generic Name: Surgical plume evacuation system filter FDA UDI
Device Name: Smoke Evacuation Sponge Guard FDA UDI
Model / Reference: 905022 FDA UDI
Description: Smoke Evacuation Sponge Guard FDA UDI

Identifiers

Primary DI / UDI-DI: 00814716020487 FDA UDI
FDA Product Code: FCZ FDA UDI
GMDN Term: Surgical plume evacuation system filter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical plume evacuation system filter

Surgimedics® by Coastal Life Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical plume evacuation system filter.

Geiger Odor Filter — DERMATOLOGIC LAB AND SUPPLY, INC. · Class II
VIROSAFE — Conmed Corporation · Class II
Geiger Smoke Evacuator Filter — DERMATOLOGIC LAB AND SUPPLY, INC. · Class II
CONMED — Conmed Corporation · Class II
Neptune — Stryker Corp. · Class II
VIROSAFE — Conmed Corporation · Class II
Geiger Smoke Evacuator Filter — DERMATOLOGIC LAB AND SUPPLY, INC. · Class II
Geiger Smoke Evacuator Filter — DERMATOLOGIC LAB AND SUPPLY, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Coastal Life Technologies, Inc.

Sources (1)

FDA UDI e6695f5e-23eb-4e01-afe8-ad6809c6d766 33 fields · synced Jun 6, 2026