Bioseal Inc.

FDA UDI

Class I (US FDA UDI)

by Bioseal

Identity

Trade Name: Bioseal Inc. FDA UDI
Generic Name: Intravascular extraction catheter-snare FDA UDI
Device Name: Tubing Snare Wire Set FDA UDI
Model / Reference: 4903/24 FDA UDI
Description: Tubing Snare Wire Set FDA UDI

Identifiers

Primary DI / UDI-DI: 00630094490328 FDA UDI
FDA Product Code: GAX FDA UDI
GMDN Term: Intravascular extraction catheter-snare FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.5900 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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intravascular extraction catheter-snare

Bioseal Inc. by Bioseal — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravascular extraction catheter-snare.

TourniKwik™ — MEDTRONIC, INC. · Class I
ONE Snare® — Merit Medical Systems, Inc. · Class II
NCircle — COOK INCORPORATED · Class I
EN Snare® — Merit Medical Systems, Inc. · Class II
ONO Retrieval Device — Onocor LLC · Class II
Amplatz Goose Neck™ — MEDTRONIC, INC. · Class II
Halo™ Single-Loop Microsnare Kit — Argon Medical Devices, Inc. · Class II
Halo™ Single-Loop Microsnare Kit — Argon Medical Devices, 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

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Manufacturer

Manufacturer: Bioseal

Sources (1)

FDA UDI 4bd00302-8eeb-482f-b4af-ae09cf67c63c 33 fields · synced May 30, 2026