Target

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: Target FDA UDI
Generic Name: Non-neurovascular embolization coil FDA UDI
Device Name: Helical Ultra Detachable Coil FDA UDI
Model / Reference: M0035432060 FDA UDI
Description: Helical Ultra Detachable Coil FDA UDI

Identifiers

Catalog Number: 543206 FDA UDI
Primary DI / UDI-DI: 04546540676016 FDA UDI
FDA Product Code: KRD FDA UDI
HCG FDA UDI
GMDN Term: Non-neurovascular embolization coil FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3300 FDA UDI
882.5950 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

Category: Neurovascular embolization coil Non-neurovascular embolization coil

Target by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Penumbra Coil 400 — PENUMBRA, INC. · Class II
Prestige Coil System — BALT USA LLC · Class II
ConcertoTM — Micro Therapeutics, 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: Stryker Corp.

Sources (1)

FDA UDI 1768a805-596e-4f3f-afdd-04724f594bb6 37 fields · synced May 30, 2026