EMBOLD™ Soft

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name: EMBOLD™ Soft FDA UDI
Generic Name: Non-neurovascular embolization coil FDA UDI
Device Name: Detachable Coil System FDA UDI
Model / Reference: M001394250020080 FDA UDI
Description: Detachable Coil System FDA UDI

Identifiers

Catalog Number: M001394250020080 FDA UDI
Primary DI / UDI-DI: 00191506026394 FDA UDI
FDA Product Code: KRD FDA UDI
GMDN Term: Non-neurovascular embolization coil FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 2 Millimeter FDA UDI
Length — 8 Centimeter FDA UDI

Category: Non-neurovascular embolization coil

EMBOLD™ Soft by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-neurovascular embolization coil.

ConcertoTM — Micro Therapeutics, Inc. · Class II
Target — Stryker Corp. · Class II
Prestige Coil System — BALT USA LLC · Class II
Optima Coil System — BALT USA LLC · Class II
Nester — COOK INCORPORATED · Class II
ConcertoTM — Micro Therapeutics, Inc. · Class II
TARGET — Stryker Corp. · Class II
Penumbra Coil 400 — PENUMBRA, 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 II	Pending data

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Manufacturer

Manufacturer: Boston Scientific

Sources (1)

FDA UDI 8032f5f2-64ab-4590-a27e-bb202568b38b 35 fields · synced Jun 8, 2026